Cleared Traditional

K895162 - TRAUMAFUSE TRACH SHIELD

K895162 is an FDA 510(k) clearance for TRAUMAFUSE TRACH SHIELD, manufactured by The Traumafuse Co.. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K895162 · The Traumafuse Co. · Anesthesiology device
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Jan 1990
Decision
140d
Days
Class 2
Risk

K895162 is an FDA 510(k) clearance for the TRAUMAFUSE TRACH SHIELD. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by The Traumafuse Co. (Allentown, US). The FDA issued a Cleared decision on January 9, 1990 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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 The Traumafuse Co. devices

FDA 510(k) Submission Details - K895162

510(k) Number K895162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1989
Decision Date January 09, 1990
Days to Decision 140 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 140d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTO Device Classification - Class 2, Special Controls

Product Code BTO Tube, Tracheostomy (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTO Tube, Tracheostomy (w/wo Connector)

All 69
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K895162.
D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBES
K903730 · Concord/Portex · Sep 1990
SHILEY PHONATION VALVE
K900548 · Shiley, Inc. · Apr 1990
TRACHEOSTOMY TRAY
K896798 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
HEIMLICH MICRO TRACH
K895130 · Ballard Medical Products · Nov 1989
HOOD PEDIATRIC TRACHEOSTOMY TUBE
K893866 · Hood Laboratories · Aug 1989
SHILEY PERC TRACHEOSTOMY SYSTEM
K884730 · Shiley, Inc. · Jan 1989