FDA product code · Obstetrics and gynecology

Pelvic Exam Kit

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

MLTClass II21 CFR 884.45301 decision since 19945 recalls

1 FDA decision since 1994. 5 recalls name this code, 0 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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.

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 MLT 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 · MLT

FDA has decided no MLT device since 2007.

Median 510(k) review, days · MLT

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

Recalls per year · MLT

1in 2024

2007high 2 (2019) · low 0 (2007)2026

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

Adverse event reports per year · MLT

1in 2019

2007high 1 (2019) · low 0 (2007)2025

MAUDE reports naming product code MLT, 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	0
2018	—	0	0
2019	—	2	1
2020	—	0	0
2021	—	0	0
2022	—	0	0
2023	—	0	0
2024	—	1	0
2025	—	0	0
2026	—	2	—

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

Planning a device in MLT? 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

Pelvic Exam Kit

What has FDA decided in MLT lately?

What has been recalled in MLT lately?

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