FDA product code · Obstetrics and gynecology

Labor And Delivery Kit

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

MLSClass II21 CFR 884.45306 decisions since 199419 recalls

6 FDA decisions since 1994. 19 recalls name this code, 1 of them Class I.

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance

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 MLS 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 · MLS

FDA has decided no MLS device since 2007.

Median 510(k) review, days · MLS

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

Recalls per year · MLS

7so far in 2026, the most since 2007

2007high 7 (2026) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MLS

10in 2025

2007high 14 (2024) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	0	0
2011	—	0	0
2012	—	0	0
2013	—	0	0
2014	—	0	0
2015	—	0	0
2016	—	0	0
2017	—	0	1
2018	—	0	1
2019	—	0	1
2020	—	1	3
2021	—	2	2
2022	—	1	9
2023	—	1	5
2024	—	5 (1)	14
2025	—	2	10
2026	—	7	—

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

Planning a device in MLS? 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 884.4530.

OHL Pap Smear Kit HHF Remover, Intrauterine Device, Contraceptive…PGK Cannula, Injector, Uterine, Endometrial Biopsy PVR D&C Tray HGE Amniotome PBQ Fixation, Non-Absorbable Or Absorbable, For…HHO Screw, Fibroid, Gynecological FHJ Shield, Circumcision HDH Needle, Cerclage, Gynecological OQY Intrauterine Tamponade Balloon HHM Sound, Uterine MDG System, Intrafallopian Cannula

Labor And Delivery Kit

What has FDA decided in MLS lately?

What has been recalled in MLS lately?

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