510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801148Substantially Equivalent

Hemogastat

Therapac, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801148 is the FDA 510(k) clearance record for HEMOGASTAT, a class I device, cleared for Therapac, Inc. on under FDA product code JRR (Regulator, Temperature). FDA records list one 510(k) clearance for Therapac, Inc. As of , FDA records show no recalls naming K801148.

Clearance record

Decision date
Received
(27 days to decision)
Product code
JRR Regulator, Temperature
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Therapac, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JRR

Trailing 12 months

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

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