510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K874410Substantially Equivalent

Cumevac

Cumes-Honikman Partnership, Santa Barbara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874410 is the FDA 510(k) clearance record for CUMEVAC, a class I device, cleared for Cumes-Honikman Partnership on under FDA product code FFD (Evacuator, Bladder, Manually Operated). FDA records list one 510(k) clearance for Cumes-Honikman Partnership. As of , FDA records show no recalls naming K874410.

Clearance record

Decision date
Received
(36 days to decision)
Product code
FFD Evacuator, Bladder, Manually Operated
Regulation
21 CFR 876.4370
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Cumes-Honikman Partnership 927 N. Kellogg Ave., Santa Barbara CA
Third party review
No

Clearances, product code FFD

Trailing 12 months

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

FDA records show no clearances under product code FFD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FFD, 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