Maternal & Newborn Atlas
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Regulatory decisions

Approvals, clearances, recalls and other decisions of a regulator on a product, with the pathway where the record names one.

23 events of 139. A year or a month is never shown as a day, and a year-only date sorts below the dated events of that year. Expected future events are on the calendar.

2026 1

  1. Clearance Jada System (intrauterine vacuum device)

    Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K253642 · Where: United States

    Source: FDA 510(k) premarket notification K253642: Jada System (Jada-2002) (openFDA record)

2025 1

  1. Clearance Elecsys sFlt-1 and Elecsys PlGF (Roche)

    Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K241453 · Where: United States

    Sources: FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics); 21 CFR 862.1602, Prognostic test for development or progression of preeclampsia (eCFR)

2023 6

  1. Clearance Novii wireless patch system (fetal heart rate from the abdomen)

    Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K231964 · Where: United States

    Source: FDA 510(k) premarket notification K231964, Novii+ Wireless Patch System (Datex Ohmeda)

  2. Approval Abrysvo (RSV vaccine, Pfizer)

    Authority: U.S. Food and Drug Administration · Pathway: BLA · Submission: BLA125768 · Where: United States

    Sources: FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023; FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release); ABRYSVO (FDA CBER product page); Respiratory Syncytial Virus Infections (MedlinePlus health topic)

  3. Approval Zurzuvae (zuranolone)

    Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA217369 · Where: United States

    Sources: FDA approves first oral treatment for postpartum depression (FDA press announcement); openFDA drugsfda record for NDA217369; ZURZUVAE drug label (openFDA record, set id f18e53b0-d0bb-422d-8de7-ab64b7292b29)

  4. Approval Beyfortus (nirsevimab)

    Authority: U.S. Food and Drug Administration · Pathway: BLA · Submission: BLA761328 · Where: United States

    Sources: Drugs@FDA record for BLA761328 (BEYFORTUS), openFDA drugsfda; BEYFORTUS (nirsevimab-alip) injection label, openFDA drug label (set id 2f08fa60-f674-432d-801b-1f9514bd9b39)

  5. Granted SNOO Smart Sleeper (infant bassinet with supine-position system)

    Authority: U.S. Food and Drug Administration · Pathway: De Novo · Submission: DEN210039 · Where: United States

    Sources: FDA De Novo DEN210039: SNOO Smart Sleeper (openFDA record); De Novo classification request for SNOO Smart Sleeper (DEN210039), decision summary; 21 CFR 880.5690 Infant supine sleep system

  6. Supplemental approval Eylea (aflibercept) for retinopathy of prematurity

    Authority: U.S. Food and Drug Administration · Pathway: BLA · Submission: BLA125387 · Where: United States

    Sources: FDA application BLA125387, EYLEA: openFDA Drugs@FDA record; FDA supplement approval letter, BLA 125387/S-075, Eylea (aflibercept) Injection; Eylea prescribing information for BLA125387: openFDA drug label record

2022 1

  1. Clearance INVU by Nuvo (maternal-fetal monitoring belt)

    Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K221046 · Where: United States

    Source: FDA 510(k) premarket notification K221046, Invu by Nuvo (Nuvo-Group Ltd), Special 510(k)

2021 2

  1. Clearance Jada System (intrauterine vacuum device)

    Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K212757 · Where: United States

    Source: FDA 510(k) premarket notification K212757: Jada System (openFDA record)

  2. Clearance INVU by Nuvo (maternal-fetal monitoring belt)

    Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K210025 · Where: United States

    Source: FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

2020 2

  1. Clearance Jada System (intrauterine vacuum device)

    Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K201199 · Where: United States

    Source: FDA 510(k) premarket notification K201199: Jada System (openFDA record)

  2. Clearance INVU by Nuvo (maternal-fetal monitoring belt)

    Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K191401 · Where: United States

    Sources: FDA 510(k) premarket notification K191401, PregSense (Nuvo-Group Ltd); FDA 510(k) premarket notification K210025, INVU by Nuvo (Nuvo-Group Ltd)

2019 1

  1. Approval Zulresso (brexanolone injection)

    Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA211371 · Where: United States

    Sources: openFDA drugsfda record for NDA211371; NDA 211371 approval letter for Zulresso (brexanolone) injection; ZULRESSO (brexanolone) injection prescribing information, 2019 label; ZULRESSO (brexanolone) injection prescribing information, 2022 label (supplement 7)

2017 1

  1. Clearance Bakri Postpartum Balloon

    Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K170622 · Where: United States

    Source: FDA 510(k) premarket notification K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (openFDA record)

2014 2

  1. Clearance Draeger Jaundice Meter JM-105

    Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K133175 · Where: United States

    Source: FDA 510(k) premarket notification K133175: Draeger Jaundice Meter JM-105 (openFDA record and the FDA clearance letter with indications for use)

  2. Clearance Novii wireless patch system (fetal heart rate from the abdomen)

    Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K140862 · Where: United States

    Source: FDA 510(k) premarket notification K140862, Monica Novii Wireless Patch System (Monica Healthcare Ltd)

2013 1

  1. Clearance Cook Cervical Ripening Balloon

    Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K131206 · Where: United States

    Source: FDA 510(k) premarket notification K131206: COOK CERVICAL RIPENING BALLOON (openFDA record)

2010 1

  1. Clearance Fisher and Paykel Bubble CPAP System

    Authority: U.S. Food and Drug Administration · Pathway: 510(k) · Submission: K100011 · Where: United States

    Source: FDA 510(k) premarket notification K100011: FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM (openFDA record)

1999 2

  1. Approval Curosurf (poractant alfa)

    Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA020744 · Where: United States

    Sources: FDA approval letter, NDA 20-744, Curosurf (poractant alfa) Intratracheal Suspension (1999); FDA application BLA020744, CUROSURF: openFDA Drugs@FDA record; Curosurf prescribing information for BLA020744: openFDA drug label record

  2. Approval Cafcit (caffeine citrate)

    Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA020793 · Where: United States

    Sources: FDA application NDA020793, CAFCIT: openFDA Drugs@FDA record; Caffeine citrate injection prescribing information for NDA020793: openFDA drug label record

1995 1

  1. Approval Cervidil (dinoprostone vaginal insert)

    Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA020411 · Where: United States

    Sources: FDA new drug application NDA020411, CERVIDIL: openFDA Drugs@FDA record and Drugs@FDA approval history page; CERVIDIL drug label (openFDA record, set id f3bc9031-0620-4a50-b440-f661cadfeb1d)

1980 1

  1. Approval Pitocin (oxytocin injection)

    Authority: U.S. Food and Drug Administration · Pathway: NDA · Submission: NDA018261 · Where: United States

    Sources: FDA new drug application NDA018261, PITOCIN: openFDA Drugs@FDA record and Drugs@FDA approval history page; Pitocin drug label (openFDA record, set id 6e5a66fc-e507-497c-b5ce-44a8c95898ad)