510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012178Substantially Equivalent

Fresenius C.a.t.s; Ati Autotransfusion Set; Psq Plasma Sequestration Set; Psq-Dd Plasma Sequestration Direct Draw

Fresenius Hemotechnology, Inc., Redmond WA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K012178 is the FDA 510(k) clearance record for FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW, a class II device, cleared for Fresenius Hemotechnology, Inc. on under FDA product code CAC (Apparatus, Autotransfusion). FDA records list 3 510(k) clearances for Fresenius Hemotechnology, Inc., from to . As of , FDA records show one recall naming K012178.

Clearance record

Decision date
Received
(11 days to decision)
Product code
CAC Apparatus, Autotransfusion
Regulation
21 CFR 868.5830
Device class
Class II
Review panel
Anesthesiology
Applicant
Fresenius Hemotechnology, Inc. 6675 185th Ave. NE, Suite 100, Redmond WA
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