Cleared Traditional

K851874 - OR TUBE RESTRAINT

K851874 is an FDA 510(k) clearance for OR TUBE RESTRAINT, manufactured by Kinetic Concepts, Inc.. The device is a Class 1 Anesthesiology device with product code CBH cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K851874 · Kinetic Concepts, Inc. · Anesthesiology device
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Aug 1985
Decision
101d
Days
Class 1
Risk

K851874 is an FDA 510(k) clearance for the OR TUBE RESTRAINT. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by Kinetic Concepts, Inc. (San Antonio, US). The FDA issued a Cleared decision on August 8, 1985 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5770 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kinetic Concepts, Inc. devices

FDA 510(k) Submission Details - K851874

510(k) Number K851874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1985
Decision Date August 08, 1985
Days to Decision 101 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 140d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

CBH Device Classification - Class 1, General Controls

Product Code CBH Device, Fixation, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5770
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CBH Device, Fixation, Tracheal Tube

All 18
Devices cleared under the same product code (CBH) and FDA review panel - the closest regulatory comparables to K851874.
BABY E.T. TAPE(TM)
K871560 · B&B Medical Technologies, Inc. · May 1987
E. T. TAPE ENDOTRACHEAL TUBE HOLDER
K862084 · B&B Medical Technologies, Inc. · Jun 1986
RESPIRONICS SECUREASY
K860845 · Respironics, Inc. · Mar 1986
RESPIRONICS ENDO TUBE CONTROL SYS
K822794 · Respironics, Inc. · Oct 1982
N-D0-SURE
K811185 · Ackrad Laboratories · Jun 1981
ENDOTRACHEAL TUBE HOLDER
K802601 · Hudson Oxygen Therapy Sales Co. · Dec 1980