Cleared Traditional

K923591 - PALA-NATE

K923591 is an FDA 510(k) clearance for PALA-NATE, manufactured by Gesco Intl., Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K923591 · Gesco Intl., Inc. · Anesthesiology device
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Mar 1993
Decision
239d
Days
Class 2
Risk

K923591 is an FDA 510(k) clearance for the PALA-NATE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Gesco Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on March 16, 1993 after a review of 239 days - an extended review 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: 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 - K923591

510(k) Number K923591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1992
Decision Date March 16, 1993
Days to Decision 239 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 140d · This submission: 239d
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 218
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K923591.
XOMED TREACE JET VENTILATION TUBE
K922880 · Xomed-Treace, Inc. · Apr 1993
ENDOGRIP
K926498 · Biomedix, Inc. · Apr 1993
TRACHEOSTOMY T-TUBE
K930114 · Invotec International, Inc. · Mar 1993
TRACHEAL TUBE FIXATION DEVICE
K930179 · Garrett Medical Products · Mar 1993
DISPOSABLE UNCUFFED ENDOTRACHEAL TUBE
K925855 · Coast Medical Corp. · Feb 1993
SAFE-T-TUBE RADIOPAQUE
K930150 · Boston Medical Products, Inc. · Feb 1993
K923591 · PALA-NATE
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