510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K081266Substantially Equivalent

Mercury Medical PEEP Valve

Mercury Enterprizes dba Mercury Medical, Clearwater FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K081266 is the FDA 510(k) clearance record for MERCURY MEDICAL PEEP VALVE, a class II device, cleared for Mercury Enterprizes Dba Mercury Medical on under FDA product code BYE (Attachment, Breathing, Positive End Expiratory Pressure). FDA records list one 510(k) clearance for Mercury Enterprizes Dba Mercury Medical. As of , FDA records show no recalls naming K081266.

Clearance record

Decision date
Received
(304 days to decision)
Product code
BYE Attachment, Breathing, Positive End Expiratory Pressure
Regulation
21 CFR 868.5965
Device class
Class II
Review panel
Anesthesiology
Applicant
Mercury Enterprizes Dba Mercury Medical 11300 49th St. N., Clearwater FL
510(k) summary
Statement
Third party review
No

Clearances, product code BYE

Trailing 12 months

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

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