510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992785Substantially Equivalent

Ibc Floguard, Model 6050

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

K992785 is the FDA 510(k) clearance record for IBC FLOGUARD, MODEL 6050, a class II device, cleared for International Biophysics Corp. on under FDA product code MJJ (Cpb Check Valve, Retrograde Flow, In-Line). FDA records list 14 510(k) clearances for International Biophysics Corp., from to . As of , FDA records show no recalls naming K992785.

Clearance record

Decision date
Received
(148 days to decision)
Product code
MJJ Cpb Check Valve, Retrograde Flow, In-Line
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 MJJ

Trailing 12 months

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

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