510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941492Substantially Equivalent

Pressure Relief Valve

Circulatory Technology, Inc., Oyster Bay NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941492 is the FDA 510(k) clearance record for PRESSURE RELIEF VALVE, a class II device, cleared for Circulatory Technology, Inc. on under FDA product code MNJ (Valve, Pressure Relief, Cardiopulmonary Bypass). FDA records list 9 510(k) clearances for Circulatory Technology, Inc., from to . As of , FDA records show no recalls naming K941492.

Clearance record

Decision date
Received
(212 days to decision)
Product code
MNJ Valve, Pressure Relief, Cardiopulmonary Bypass
Regulation
21 CFR 870.4400
Device class
Class II
Review panel
Cardiovascular
Applicant
Circulatory Technology, Inc. 21 Singworth St., Oyster Bay NY
510(k) summary
Statement
Third party review
No

Clearances, product code MNJ

Trailing 12 months

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

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