510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K802199Substantially Equivalent

Stat-Crit Hematocrit Measuring Instru

United States Surgical, A Division of Tyco Healthc, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802199 is the FDA 510(k) clearance record for STAT-CRIT HEMATOCRIT MEASURING INSTRU, a class II device, cleared for United States Surgical, A Division of Tyco Healthc on under FDA product code GKF (Instrument, Hematocrit, Automated). FDA records list 218 510(k) clearances for United States Surgical, A Division of Tyco Healthc, from to . As of , FDA records show no recalls naming K802199.

Clearance record

Decision date
Received
(147 days to decision)
Product code
GKF Instrument, Hematocrit, Automated
Regulation
21 CFR 864.5600
Device class
Class II
Review panel
Hematology
Applicant
United States Surgical, A Division of Tyco Healthc 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GKF

Trailing 12 months

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

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