FDA product code · Obstetrics and gynecology

Oximeter, Fetal Pulse

Name: FDA decisions, review times, recalls and adverse event reports for product code MMA
Creator: 510(k) Report

MMAClass IIIPMA required3 decisions since 20000 recalls

3 FDA decisions since 2000. No recall names this code.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, obstetrics and gynecology panel

Twenty years of MMA at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · MMA

FDA has decided no MMA device since 2007.

Median 510(k) review, days · MMA

Too few MMA 510(k)s in any year since 2007 to give a median.

Recalls per year · MMA

No recall names MMA since 2007.

Adverse event reports per year · MMA

1in 2021

2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code MMA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	1
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	1
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

FIG. 1 — MMA by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MMA? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Oximeter, Fetal Pulse

What has FDA decided in MMA lately?