Cleared Traditional

K942628 - ESOPHAGEAL INTUBATION DETECTOR BULB

K942628 is an FDA 510(k) clearance for ESOPHAGEAL INTUBATION DETECTOR BULB, manufactured by Wolfe Tory Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K942628 · Wolfe Tory Medical, Inc. · Anesthesiology device
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Aug 1994
Decision
77d
Days
Class 2
Risk

K942628 is an FDA 510(k) clearance for the ESOPHAGEAL INTUBATION DETECTOR BULB. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Wolfe Tory Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 18, 1994 after a review of 77 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 Wolfe Tory Medical, Inc. devices

FDA 510(k) Submission Details - K942628

510(k) Number K942628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1994
Decision Date August 18, 1994
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 140d · This submission: 77d
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 165
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K942628.
QUICK-LOCK
K945816 · B&B Medical Technologies, Inc. · Jan 1995
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K945455 · Vital Signs, Inc. · Dec 1994
SURE-LOCK VENTILATOR TUBING HOLDER
K944324 · B&B Medical Technologies, Inc. · Nov 1994
COLIBRI
K940041 · Icor AB · Jul 1994
ENDOPLUS
K941969 · Wembley Rubber Products (M) Sdn Bhd · Jun 1994
RAE II TRACHEAL TUBE
K941246 · Mallinckrodt Medical · Apr 1994