Cleared Traditional

K900457 - CUFFED LINDER NASOTRACHEAL AIRWAY

K900457 is an FDA 510(k) clearance for CUFFED LINDER NASOTRACHEAL AIRWAY, 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 76-day FDA review.

K900457 · Polamedco, Inc. · Anesthesiology device
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Apr 1990
Decision
76d
Days
Class 2
Risk

K900457 is an FDA 510(k) clearance for the CUFFED LINDER NASOTRACHEAL AIRWAY. 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 April 16, 1990 after a review of 76 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 - K900457

510(k) Number K900457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1990
Decision Date April 16, 1990
Days to Decision 76 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 140d · This submission: 76d
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 K900457.
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
KENDALL CURITY ENDOTRACHEAL TUBES
K892432 · The Kendal Co. · Jun 1989
LINDER NASOTRACHEAL AIRWAY
K881496 · Polamedco, Inc. · May 1988
NDYAG LASER TRACHEAL TUBE
K880960 · Sheridan Catheter Corp. · Apr 1988