510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K992964Substantially Equivalent

Ibc Vent Valve, Model 1400

International Biophysics Corp., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992964 is the FDA 510(k) clearance record for IBC VENT VALVE, MODEL 1400, a class II device, cleared for International Biophysics Corp. on under FDA product code MNJ (Valve, Pressure Relief, Cardiopulmonary Bypass). FDA records list 14 510(k) clearances for International Biophysics Corp., from to . As of , FDA records show no recalls naming K992964.

Clearance record

Decision date
Received
(78 days to decision)
Product code
MNJ Valve, Pressure Relief, Cardiopulmonary Bypass
Regulation
21 CFR 870.4400
Device class
Class II
Review panel
Cardiovascular
Applicant
International Biophysics Corp. 4020 S. Industrial Dr., Austin TX
510(k) summary
Summary
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