Cleared Traditional

K895132 - CONNELL-STEPHENS ENDO ANESS TUBE

K895132 is an FDA 510(k) clearance for CONNELL-STEPHENS ENDO ANESS TUBE, manufactured by The Traumafuse Co.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K895132 · The Traumafuse Co. · Anesthesiology device
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Oct 1989
Decision
57d
Days
Class 2
Risk

K895132 is an FDA 510(k) clearance for the CONNELL-STEPHENS ENDO ANESS TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by The Traumafuse Co. (Allentown, US). The FDA issued a Cleared decision on October 13, 1989 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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 The Traumafuse Co. devices

FDA 510(k) Submission Details - K895132

510(k) Number K895132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1989
Decision Date October 13, 1989
Days to Decision 57 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 140d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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 - BTR Tube, Tracheal (w/wo Connector)

All 185
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K895132.
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