510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925863Substantially Equivalent

Spuncrit

bioMerieux, Inc., Bethlehem PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925863 is the FDA 510(k) clearance record for SPUNCRIT, a class II device, cleared for bioMerieux, Inc. on under FDA product code GKG (Centrifuge, Hematocrit). FDA records list 408 510(k) clearances for bioMerieux, Inc., from to . As of , FDA records show no recalls naming K925863.

Clearance record

Decision date
Received
(78 days to decision)
Product code
GKG Centrifuge, Hematocrit
Regulation
21 CFR 864.6400
Device class
Class II
Review panel
Hematology
Applicant
bioMerieux, Inc. 170-57 S. Commerce Way, Bethlehem PA
510(k) summary
Summary
Third party review
No

Clearances, product code GKG

Trailing 12 months

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

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