Cleared Traditional

K921077 - DISPOSABLE INTUBATION KITS

K921077 is an FDA 510(k) clearance for DISPOSABLE INTUBATION KITS, 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 176-day FDA review.

K921077 · Coast Medical Corp. · Anesthesiology device
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Aug 1992
Decision
176d
Days
Class 2
Risk

K921077 is an FDA 510(k) clearance for the DISPOSABLE INTUBATION KITS. 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 August 25, 1992 after a review of 176 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 - K921077

510(k) Number K921077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1992
Decision Date August 25, 1992
Days to Decision 176 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
36d slower than avg
Panel avg: 140d · This submission: 176d
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 K921077.
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
ENDOTRACHEAL CPAP SET
K915277 · Vital Signs, Inc. · Mar 1992
POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES
K920900 · Polamedco, Inc. · Mar 1992
BIVONA SLEEP APNEA TUBE
K915799 · Bivona Medical Technologies · Feb 1992