Breast pumps

A breast pump is a device a breastfeeding woman uses to express (draw out) her milk. FDA regulates breast pumps as medical devices. The pump can also be used to keep up or increase milk supply or to relieve engorged breasts and plugged milk ducts.

  • Technology
  • In this atlas

Overview

Technical summary

FDA's consumer page (content current as of 26 March 2018) calls breast pumps medical devices regulated by FDA and describes their uses. Only the landing page was read; the sub-pages on types, choosing, buying, using and cleaning a pump, and any FDA clearance record, were not. The page is general information, not medical advice. The recipient is the breastfeeding mother.

How it works

A device that draws milk from the breast so that it can be fed or stored, or to relieve engorgement or maintain supply.

Strengths

  • Can be used as a supplement to breastfeeding (FDA)
  • Some pumps are designed to mimic the suckling of a nursing baby (FDA)

Limitations

  • FDA's page says it is not intended to provide medical advice
  • The page is more than eight years old and the details of choosing and cleaning were not read

Required infrastructure

None stated in this record.

Claims and evidence

Context Women who use a breast pump (FDA consumer page)

Recipient
Maternal
Population
Women who breastfeed or express breast milk, as the FDA consumer page on breast pumps addresses them.
Care setting
Home, work and travel (the page mentions returning to work and travelling).
Geography
United States (FDA consumer page)
Life stage
The period of lactation after birth
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (consumer information).
Eligibility: 1 inclusion criterion; 1 exclusion criterion
Included
  • Women who breastfeed or express breast milk
Excluded
  • Not stated in the source that was read
  • Regulatory Guidance Certainty not assessed

    FDA's consumer page says breast pumps are medical devices regulated by FDA. It says they are often used by breastfeeding women to express their breast milk, and can also be used to maintain or increase milk supply and to relieve engorged breasts and plugged milk ducts. FDA says a pump can be used as a supplement to breastfeeding and that some pumps are designed to mimic the suckling of a nursing baby. The page states that it gives general information and is not intended to provide medical advice.

    Applies to Maternal
    • Women who breastfeed or express breast milk, as the FDA consumer page on breast pumps addresses them.
    • Home, work and travel (the page mentions returning to work and travelling).
    • United States (FDA consumer page)
    • The period of lactation after birth
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (consumer information).
    Certainty method
    Not assessed
    Limitations
    The page says its content was current as of 26 March 2018, so it is more than eight years old. Only the landing page was read, not the pages on choosing, buying, using or cleaning a pump, and no FDA clearance record for a particular pump was read. The page does not say which pump types are cleared for which uses.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (5)
    1. Supports Breast Pumps (FDA consumer page)

      Regulator · U.S. Food and Drug Administration · Edition FDA consumer page as shown on 2026-10-15; it says content current as of 03/26/2018, so it is more than eight years old. Only the landing page was read, not the sub-pages on choosing, buying or cleaning a pump.

      Locator
      Paragraph 1, sentence 1
      How it applies
      FDA web page.
      Retrieved
      Source effective date
      2018-03-26
      Source state
      Current
      Snapshot hash
      bdb383531b62377eb380fd6c4ebbbc85a00ae70a78b2a901e377834f33070688
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.
    2. Supports Breast Pumps (FDA consumer page)

      Regulator · U.S. Food and Drug Administration · Edition FDA consumer page as shown on 2026-10-15; it says content current as of 03/26/2018, so it is more than eight years old. Only the landing page was read, not the sub-pages on choosing, buying or cleaning a pump.

      Locator
      Paragraph 1, sentence 2
      How it applies
      FDA web page.
      Retrieved
      Source effective date
      2018-03-26
      Source state
      Current
      Snapshot hash
      bdb383531b62377eb380fd6c4ebbbc85a00ae70a78b2a901e377834f33070688
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.
    3. Supports Breast Pumps (FDA consumer page)

      Regulator · U.S. Food and Drug Administration · Edition FDA consumer page as shown on 2026-10-15; it says content current as of 03/26/2018, so it is more than eight years old. Only the landing page was read, not the sub-pages on choosing, buying or cleaning a pump.

      Locator
      Paragraph 1, sentences 2 and 3
      How it applies
      FDA web page.
      Retrieved
      Source effective date
      2018-03-26
      Source state
      Current
      Snapshot hash
      bdb383531b62377eb380fd6c4ebbbc85a00ae70a78b2a901e377834f33070688
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.
    4. Supports Breast Pumps (FDA consumer page)

      Regulator · U.S. Food and Drug Administration · Edition FDA consumer page as shown on 2026-10-15; it says content current as of 03/26/2018, so it is more than eight years old. Only the landing page was read, not the sub-pages on choosing, buying or cleaning a pump.

      Locator
      Paragraph 2, sentence 2
      How it applies
      FDA web page.
      Retrieved
      Source effective date
      2018-03-26
      Source state
      Current
      Snapshot hash
      bdb383531b62377eb380fd6c4ebbbc85a00ae70a78b2a901e377834f33070688
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.
    5. Background Breast Pumps (FDA consumer page)

      Regulator · U.S. Food and Drug Administration · Edition FDA consumer page as shown on 2026-10-15; it says content current as of 03/26/2018, so it is more than eight years old. Only the landing page was read, not the sub-pages on choosing, buying or cleaning a pump.

      Locator
      Paragraph 3, sentence 1 (part)
      How it applies
      FDA web page (context for the claim).
      Retrieved
      Source effective date
      2018-03-26
      Source state
      Current
      Snapshot hash
      bdb383531b62377eb380fd6c4ebbbc85a00ae70a78b2a901e377834f33070688
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

Record details

Record id
maternal:breast-pump
Content hash
4133fe56c4c51e9e96fb788893bded70d7ab4ce6cfd8a3a35cdc245e658d3384