510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K922031Substantially Equivalent

Hms Purple and Black Heparin Cartridges & Control

Medtronic Hemotec, Inc., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922031 is the FDA 510(k) clearance record for HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL, a class II device, cleared for Medtronic Hemotec, Inc. on under FDA product code JOX (Analyzer, Heparin, Automated). FDA records list 5 510(k) clearances for Medtronic Hemotec, Inc., from to . As of , FDA records show no recalls naming K922031.

Clearance record

Decision date
Received
(81 days to decision)
Product code
JOX Analyzer, Heparin, Automated
Regulation
21 CFR 864.5680
Device class
Class II
Review panel
Hematology
Applicant
Medtronic Hemotec, Inc. 7103 S. Revere Pkwy., Englewood CO
510(k) summary
Statement
Third party review
No

Clearances, product code JOX

Trailing 12 months

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

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