510(k) Report

FDA product code · Obstetrics and gynecology

Accessory, Assisted Reproduction

MQGClass II21 CFR 884.6120510(k) required47 decisions since 19983 recalls

47 FDA decisions since 1998. 510(k) reviews decided 2021–2025 took a median of 261 days (half between 260 and 263). 3 recalls name this code, 0 of them Class I. The most-cited predicate is K092183, named by 4 later devices.

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 MQG 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 · MQG

1in 2025

2011: 42012: 12014: 32016: 22017: 22018: 32024: 12025: 12026 (partial year): 2
2007high 4 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQG

135in 2018

2011: 137 days median2014: 236 days median2018: 135 days median
2007high 236 (2014) · low 135 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQG

1in 2023

2019: 12020: 12023: 1
2007high 1 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQG

1in 2025

2016: 12019: 22020: 32023: 32024: 12025: 1
2007high 3 (2020) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
2011413700
20121—00
20130—00
2014323600
20150—00
20162—01
20172—00
2018313500
20190—12
20200—13
20210—00
20220—00
20230—13
20241—01
20251—01
20262—0—
FIG. 1 — MQG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MQG? 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

Related product codes

Other codes under 21 CFR 884.6120.