Cleared Traditional

K812943 - SLICK ENDOTRACHEAL TUBE

K812943 is an FDA 510(k) clearance for SLICK ENDOTRACHEAL TUBE, 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 17-day FDA review.

K812943 · Polamedco, Inc. · Anesthesiology device
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Nov 1981
Decision
17d
Days
Class 2
Risk

K812943 is an FDA 510(k) clearance for the SLICK ENDOTRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Polamedco, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 6, 1981 after a review of 17 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 - K812943

510(k) Number K812943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1981
Decision Date November 06, 1981
Days to Decision 17 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
123d faster than avg
Panel avg: 140d · This submission: 17d
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 K812943.
TRACELON
K821180 · Terumo Medical Corp. · May 1982
SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL
K821027 · Shiley, Inc. · May 1982
VYGON ENDOTRACHEAL TUBES
K813373 · Exco, Inc. · Dec 1981
ARGYLE TARTAN TRACHEAL TUBE
K811937 · Sherwood Medical Co. · Jul 1981
LINDHOLM ANATOMICAL TRACHEAL TUBE
K811888 · Mallinckrodt Critical Care · Jul 1981
SLICK SET W/SURELOC EXTERNAL CONNECTOR
K810151 · Polamedco, Inc. · Feb 1981