510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950397Substantially Equivalent

System 22 Valve

Turnkey Intergration USA, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950397 is the FDA 510(k) clearance record for SYSTEM 22 VALVE, a class II device, cleared for Turnkey Intergration USA, Inc. on under FDA product code BYE (Attachment, Breathing, Positive End Expiratory Pressure). FDA records list 26 510(k) clearances for Turnkey Intergration USA, Inc., from to . As of , FDA records show no recalls naming K950397.

Clearance record

Decision date
Received
(72 days to decision)
Product code
BYE Attachment, Breathing, Positive End Expiratory Pressure
Regulation
21 CFR 868.5965
Device class
Class II
Review panel
Anesthesiology
Applicant
Turnkey Intergration USA, Inc. 6060 Castleway Dr. W., Indianapolis IN
510(k) summary
Statement
Third party review
No

Clearances, product code BYE

Trailing 12 months

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

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