510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963698Substantially Equivalent

Cm02 Cuvette, 1/2, Cm02 Cuvette, 3/8 and Cm02 Cuvette, 1/4

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

K963698 is the FDA 510(k) clearance record for CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4, a class II device, cleared for International Biophysics Corp. on under FDA product code DTY (Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass). FDA records list 14 510(k) clearances for International Biophysics Corp., from to . As of , FDA records show no recalls naming K963698.

Clearance record

Decision date
Received
(185 days to decision)
Product code
DTY Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
Regulation
21 CFR 870.4410
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 DTY

Trailing 12 months

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

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