510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K851874Substantially Equivalent

Or Tube Restraint

KCI USA, Inc., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851874 is the FDA 510(k) clearance record for OR TUBE RESTRAINT, a class I device, cleared for Kinetic Concepts, Inc. on under FDA product code CBH (Device, Fixation, Tracheal Tube). FDA records list 76 510(k) clearances for KCI USA, INC., from to . As of , FDA records show no recalls naming K851874.

Clearance record

Decision date
Received
(101 days to decision)
Product code
CBH Device, Fixation, Tracheal Tube
Regulation
21 CFR 868.5770
Device class
Class I
Review panel
Anesthesiology
Applicant
Kinetic Concepts, Inc. 4958 Stout Dr., San Antonio TX
Third party review
No

Clearances, product code CBH

Trailing 12 months

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

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