Cleared Traditional

K823757 - SURGITEK ENDOTRACHEAL TUBE, LASER RESIS

K823757 is an FDA 510(k) clearance for SURGITEK ENDOTRACHEAL TUBE, manufactured by Medical Engineering Corp.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K823757 · Medical Engineering Corp. · Anesthesiology device
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Apr 1983
Decision
135d
Days
Class 2
Risk

K823757 is an FDA 510(k) clearance for the SURGITEK ENDOTRACHEAL TUBE, LASER RESIS. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Medical Engineering Corp. (Mchenry, US). The FDA issued a Cleared decision on April 28, 1983 after a review of 135 days - within the typical 510(k) review window.

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: 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 Medical Engineering Corp. devices

FDA 510(k) Submission Details - K823757

510(k) Number K823757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1982
Decision Date April 28, 1983
Days to Decision 135 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
5d faster than avg
Panel avg: 140d · This submission: 135d
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 157
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K823757.
ARGYLE JET TRACHEAL TUBE
K833807 · Sherwood Medical Co. · Jan 1984
TRACH SWIVE/CONNECTOR
K833197 · Airlife, Inc. · Oct 1983
TRACHEAL TUBE W/ILLUMINATING LOCATER
K830631 · Mallinckrodt Critical Care · May 1983
REINFORCED SILICONE TRACHEAL TUBE
K830352 · Portex, Inc. · Mar 1983
SHERIDAN/HVT,CF, UNCUFFED
K822082 · Sheridan Catheter Corp. · Aug 1982
ARGYLE TARTAN I TRACHEAL TUBE
K821670 · Sherwood Medical Co. · Jun 1982