510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925661Substantially Equivalent

Stockert Caps1 Cardioplegic Control Module

Sorin Biomedica, Fiat, USA, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925661 is the FDA 510(k) clearance record for STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE, a class II device, cleared for Sorin Biomedica, Fiat, USA, Inc. on under FDA product code KRL (Detector, Bubble, Cardiopulmonary Bypass). FDA records list 20 510(k) clearances for Sorin Biomedica, Fiat, USA, Inc., from to . As of , FDA records show no recalls naming K925661.

Clearance record

Decision date
Received
(189 days to decision)
Product code
KRL Detector, Bubble, Cardiopulmonary Bypass
Regulation
21 CFR 870.4205
Device class
Class II
Review panel
Cardiovascular
Applicant
Sorin Biomedica, Fiat, USA, Inc. 17600 Gilette Ave., Irvine CA
510(k) summary
Summary
Third party review
No

Clearances, product code KRL

Trailing 12 months

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

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