Cleared Traditional

K854252 - TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER

K854252 is an FDA 510(k) clearance for TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TR..., manufactured by Transtracheal Systems. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K854252 · Transtracheal Systems · Anesthesiology device
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Feb 1986
Decision
104d
Days
Class 2
Risk

K854252 is an FDA 510(k) clearance for the TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Transtracheal Systems (Denver, US). The FDA issued a Cleared decision on February 3, 1986 after a review of 104 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 Transtracheal Systems devices

FDA 510(k) Submission Details - K854252

510(k) Number K854252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received October 22, 1985
Decision Date February 03, 1986
Days to Decision 104 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 140d · This submission: 104d
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 60
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K854252.
MINI-TRACH KIT
K862167 · Portex, Inc. · Aug 1986
FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES
K862267 · Bivona Medical Technologies · Jun 1986
TRACHEOSTOMY CARE KIT
K855130 · Dynarex Corp. · Mar 1986
LARYNGECTOMY TUBE, CUFFED
K860176 · Sheridan Catheter Corp. · Jan 1986
THE HOOD LIFE SAVER
K853511 · Hood Laboratories · Dec 1985
CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE
K853419 · Hood Laboratories · Dec 1985