510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904011Substantially Equivalent

Model #527 Ophthalmic Stretcher

Midmark Corp, Versailles OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904011 is the FDA 510(k) clearance record for MODEL #527 OPHTHALMIC STRETCHER, a class II device, cleared for Midmark Corp. on under FDA product code FPO (Stretcher, Wheeled). FDA records list 39 510(k) clearances for Midmark Corp., from to . As of , FDA records show no recalls naming K904011.

Clearance record

Decision date
Received
(35 days to decision)
Product code
FPO Stretcher, Wheeled
Regulation
21 CFR 880.6910
Device class
Class II
Review panel
General Hospital
Applicant
Midmark Corp. 60 Vista Dr., Versailles OH
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