510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854304Substantially Equivalent

Keymed Office Couch

Keymed, Inc., Essex Ss2 5qh England, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854304 is the FDA 510(k) clearance record for KEYMED OFFICE COUCH, a class II device, cleared for Keymed, Inc. on under FDA product code FPO (Stretcher, Wheeled). FDA records list 29 510(k) clearances for Keymed, Inc., from to . As of , FDA records show no recalls naming K854304.

Clearance record

Decision date
Received
(18 days to decision)
Product code
FPO Stretcher, Wheeled
Regulation
21 CFR 880.6910
Device class
Class II
Review panel
General Hospital
Applicant
Keymed, Inc. Keymed House, Stock Rd., Essex Ss2 5qh England, GB
Third party review
No

Clearances, product code FPO

Trailing 12 months

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

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