510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K081345Substantially Equivalent for Some Indications

Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary)

ThermoGenesis Corp., Rancho Cordova CA / Abbreviated, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K081345 is the FDA 510(k) clearance record for AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY), a class I device, cleared for Thermogenesis Corp. on under FDA product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use). FDA records list 3 510(k) clearances for Thermogenesis Corp., from to . As of , FDA records show no recalls naming K081345.

Clearance record

Decision date
Received
(57 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
Thermogenesis Corp. 2711 Citrus Rd., Rancho Cordova CA
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JQC, 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