510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K881338Substantially Equivalent

Condom-Mate Vaginal Lubricant

Upsher-Smith Laboratories, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881338 is the FDA 510(k) clearance record for CONDOM-MATE VAGINAL LUBRICANT, a class I device, cleared for Upsher-Smith Laboratories, Inc. on under FDA product code KMJ (Lubricant, Patient). FDA records list one 510(k) clearance for Upsher-Smith Laboratories, Inc. As of , FDA records show no recalls naming K881338.

Clearance record

Decision date
Received
(48 days to decision)
Product code
KMJ Lubricant, Patient
Regulation
21 CFR 880.6375
Device class
Class I
Review panel
General Hospital
Applicant
Upsher-Smith Laboratories, Inc. 14905 23rd Ave. N., Minneapolis MN
Third party review
No

Clearances, product code KMJ

Trailing 12 months

FDA records hold no clearances under product code KMJ in the trailing twelve months.

FDA records show no clearances under product code KMJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KMJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260