Cleared Traditional

K990556 - ESOPHAGEAL INTUBATION DETECTOR

K990556 is an FDA 510(k) clearance for ESOPHAGEAL INTUBATION DETECTOR, 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 32-day FDA review.

K990556 · Wolfe Tory Medical, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Mar 1999
Decision
32d
Days
Class 2
Risk

K990556 is an FDA 510(k) clearance for the ESOPHAGEAL INTUBATION DETECTOR. 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 March 26, 1999 after a review of 32 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 - K990556

510(k) Number K990556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1999
Decision Date March 26, 1999
Days to Decision 32 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 140d · This submission: 32d
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 164
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K990556.
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