Cleared Traditional

K926498 - ENDOGRIP

K926498 is an FDA 510(k) clearance for ENDOGRIP, manufactured by Biomedix, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K926498 · Biomedix, Inc. · Anesthesiology device
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Apr 1993
Decision
99d
Days
Class 2
Risk

K926498 is an FDA 510(k) clearance for the ENDOGRIP. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Biomedix, Inc. (Spencer, US). The FDA issued a Cleared decision on April 7, 1993 after a review of 99 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.

FDA 510(k) Submission Details - K926498

510(k) Number K926498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1992
Decision Date April 07, 1993
Days to Decision 99 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 140d · This submission: 99d
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 205
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K926498.
LAZER-TRACH TRACHEAL TUBE
K922894 · Sheridan Catheter Corp. · May 1993
DISPOSABLE CUFFED ENDOTRACHEAL TUBE
K925781 · Coast Medical Corp. · Apr 1993
XOMED TREACE JET VENTILATION TUBE
K922880 · Xomed-Treace, Inc. · Apr 1993
TRACHEOSTOMY T-TUBE
K930114 · Invotec International, Inc. · Mar 1993
PALA-NATE
K923591 · Gesco Intl., Inc. · Mar 1993
TRACHEAL TUBE FIXATION DEVICE
K930179 · Garrett Medical Products · Mar 1993