Cleared Traditional

K920900 - POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES

K920900 is an FDA 510(k) clearance for POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES, manufactured by Polamedco, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K920900 · Polamedco, Inc. · Anesthesiology device
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Mar 1992
Decision
21d
Days
Class 2
Risk

K920900 is an FDA 510(k) clearance for the POLAMEDCO TRACHEAL AND NASOTRACHEAL TUBES. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Polamedco, Inc. (Inglewood, US). The FDA issued a Cleared decision on March 18, 1992 after a review of 21 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Polamedco, Inc. devices

FDA 510(k) Submission Details - K920900

510(k) Number K920900 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1992
Decision Date March 18, 1992
Days to Decision 21 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
119d faster than avg
Panel avg: 140d · This submission: 21d
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 147
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K920900.
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
BIVONA SLEEP APNEA TUBE
K915799 · Bivona Medical Technologies · Feb 1992
HEALY/MONTGOMERY STENT SYSTEM (HMS SYSTEM(TM))
K912290 · Boston Medical Products, Inc. · Aug 1991
MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM)
K903876 · Boston Medical Products, Inc. · Feb 1991