510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952038Substantially Equivalent

Clean-Cuff

Instrumed, Inc., Bothell WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952038 is the FDA 510(k) clearance record for CLEAN-CUFF, a class I device, cleared for Instrumed, Inc. on under FDA product code KCY (Tourniquet, Pneumatic). FDA records list 7 510(k) clearances for Instrumed, Inc., from to . As of , FDA records show one recall naming K952038.

Clearance record

Decision date
Received
(71 days to decision)
Product code
KCY Tourniquet, Pneumatic
Regulation
21 CFR 878.5910
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Instrumed, Inc. 11818 N. Creek Pkwy. N., Bothell WA
510(k) summary
Statement
Third party review
No

Clearances, product code KCY

Trailing 12 months

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

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