Cleared Traditional

K925781 - DISPOSABLE CUFFED ENDOTRACHEAL TUBE

K925781 is an FDA 510(k) clearance for DISPOSABLE CUFFED ENDOTRACHEAL TUBE, manufactured by Coast Medical Corp.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K925781 · Coast Medical Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1993
Decision
158d
Days
Class 2
Risk

K925781 is an FDA 510(k) clearance for the DISPOSABLE CUFFED ENDOTRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Coast Medical Corp. (Orange, US). The FDA issued a Cleared decision on April 19, 1993 after a review of 158 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.

View all Coast Medical Corp. devices

FDA 510(k) Submission Details - K925781

510(k) Number K925781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1992
Decision Date April 19, 1993
Days to Decision 158 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
18d slower than avg
Panel avg: 140d · This submission: 158d
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 189
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K925781.
RUSCH AGT PVC PREF ORAL TRACH TUBE, UNCUF W/MUR EY
K931166 · Rusch, Inc. · Jun 1993
BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE
K931735 · Smiths Industries Medical Systems, Inc. · May 1993
LAZER-TRACH TRACHEAL TUBE
K922894 · Sheridan Catheter Corp. · May 1993
PALA-NATE
K923591 · Gesco Intl., Inc. · Mar 1993
SAFE-T-TUBE RADIOPAQUE
K930150 · Boston Medical Products, Inc. · Feb 1993
MECONIUM SUCTION DEVICE (MSD)
K914370 · Vital Signs, Inc. · Jan 1993