Cleared Traditional

K872277 - TRAKEFIT TRACHEOSTOMY TUBE HOLDER

K872277 is an FDA 510(k) clearance for TRAKEFIT TRACHEOSTOMY TUBE HOLDER, manufactured by Ackrad Laboratories. The device is a Class 1 Anesthesiology device with product code CBH cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K872277 · Ackrad Laboratories · Anesthesiology device
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Jul 1987
Decision
36d
Days
Class 1
Risk

K872277 is an FDA 510(k) clearance for the TRAKEFIT TRACHEOSTOMY TUBE HOLDER. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by Ackrad Laboratories (Cranford, US). The FDA issued a Cleared decision on July 21, 1987 after a review of 36 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ackrad Laboratories devices

FDA 510(k) Submission Details - K872277

510(k) Number K872277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1987
Decision Date July 21, 1987
Days to Decision 36 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
104d faster than avg
Panel avg: 140d · This submission: 36d
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 9
Devices cleared under the same product code (CBH) and FDA review panel - the closest regulatory comparables to K872277.
AMT ENDOTRACHEAL TUBE BRIDLE RETENTION SYSTEM
K140097 · Applied Medical Technology, Inc. · Sep 2014
SALTER LABS MODEL #1015
K903539 · Salter Labs · Dec 1990
RESPIRONIC'S INFANT SECUREEASY
K882079 · Respironics, Inc. · Aug 1988
RESPIRONICS SECUREASY
K860845 · Respironics, Inc. · Mar 1986
OR TUBE RESTRAINT
K851874 · Kinetic Concepts, Inc. · Aug 1985
RESPIRONICS ENDO TUBE CONTROL SYS
K822794 · Respironics, Inc. · Oct 1982