510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K994148Substantially Equivalent

3I Model(s)7426 and 7427 Celsep Centrifuge System

ZimVie US Corp LLC, Palm Beach Gardens FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994148 is the FDA 510(k) clearance record for 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM, a class I device, cleared for Implant Innovations, Inc. on under FDA product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use). FDA records list 123 510(k) clearances for ZimVie US Corp LLC, from to . As of , FDA records show no recalls naming K994148.

Clearance record

Decision date
Received
(55 days to decision)
Product code
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Implant Innovations, Inc. 4555 Riverside Dr., Palm Beach Gardens FL
510(k) summary
Summary
Third party review
No

Clearances, product code JQC

Trailing 12 months

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

FDA records show no clearances under product code JQC in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JQC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260