510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K872003Substantially Equivalent

Kinderwrap

The Kinder Co., Ypsilanti MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872003 is the FDA 510(k) clearance record for KINDERWRAP, a class I device, cleared for The Kinder Co. on under FDA product code GAX (Tourniquet, Nonpneumatic). FDA records list one 510(k) clearance for The Kinder Co. As of , FDA records show no recalls naming K872003.

Clearance record

Decision date
Received
(28 days to decision)
Product code
GAX Tourniquet, Nonpneumatic
Regulation
21 CFR 878.5900
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
The Kinder Co. 411 Greenlawn, Ypsilanti MI
Third party review
No

Clearances, product code GAX

Trailing 12 months

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

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