510(k) Report

FDA product code · General hospital

Lubricant, Vaginal, Patient

MMSClass I21 CFR 880.6375510(k) required0 decisions0 recalls

0 FDA decisions. 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, general hospital panel

Twenty years of MMS 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 · MMS

FDA has decided no MMS device since 2007.

Median 510(k) review, days · MMS

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

Recalls per year · MMS

No recall names MMS since 2007.

Adverse event reports per year · MMS

1in 2019

2007: 22009: 12010: 22011: 12012: 12019: 1
2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code MMS, 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—02
20080—00
20090—01
20100—02
20110—01
20120—01
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—
FIG. 1 — MMS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MMS? 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 880.6375.

KMJ Lubricant, PatientONK Oral Lubricant