Cleared Traditional

K894096 - STAT-TRACH(TM) VENTILATION CATHETER

K894096 is an FDA 510(k) clearance for STAT-TRACH(TM) VENTILATION CATHETER, manufactured by Statron Corp.. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K894096 · Statron Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
280d
Days
Class 2
Risk

K894096 is an FDA 510(k) clearance for the STAT-TRACH(TM) VENTILATION CATHETER. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Statron Corp. (Ashland, US). The FDA issued a Cleared decision on March 16, 1990 after a review of 280 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K894096

510(k) Number K894096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1989
Decision Date March 16, 1990
Days to Decision 280 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
140d slower than avg
Panel avg: 140d · This submission: 280d
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 91
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K894096.
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE
K901078 · L H M Ent., Inc. · May 1990
SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN STER. WATER
K901079 · L H M Ent., Inc. · May 1990
SHILEY PHONATION VALVE
K900548 · Shiley, Inc. · Apr 1990
TRACHEOSTOMY TRAY
K896798 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
TRAUMAFUSE TRACH SHIELD
K895162 · The Traumafuse Co. · Jan 1990
HEIMLICH MICRO TRACH
K895130 · Ballard Medical Products · Nov 1989
K894096 · STAT-TRACH(TM) VENTILATION CATHETER
Download PDF Statron Corp.