510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K952224Substantially Equivalent

Stryker Constavac Blood Conservation System II (Cbcii)

Stryker Corp., Kalamazoo MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952224 is the FDA 510(k) clearance record for STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII), a class II device, cleared for Stryker Instruments on under FDA product code CAC (Apparatus, Autotransfusion). FDA records list 568 510(k) clearances for STRYKER CORP., from to . As of , FDA records show 25 recalls naming K952224.

Clearance record

Decision date
Received
(189 days to decision)
Product code
CAC Apparatus, Autotransfusion
Regulation
21 CFR 868.5830
Device class
Class II
Review panel
Anesthesiology
Applicant
Stryker Instruments 4100 E. Milham Ave., Kalamazoo MI
510(k) summary
Summary
Third party review
No

Clearances, product code CAC

Trailing 12 months

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

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