Cleared Traditional

K801213 - CONCEPT ENDOTRACHEAL TUBE

K801213 is an FDA 510(k) clearance for CONCEPT ENDOTRACHEAL TUBE, manufactured by Concept, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K801213 · Concept, Inc. · Anesthesiology device
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May 1980
Decision
8d
Days
Class 2
Risk

K801213 is an FDA 510(k) clearance for the CONCEPT ENDOTRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Concept, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1980 after a review of 8 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 Concept, Inc. devices

FDA 510(k) Submission Details - K801213

510(k) Number K801213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1980
Decision Date May 28, 1980
Days to Decision 8 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
132d faster than avg
Panel avg: 140d · This submission: 8d
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 117
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K801213.
SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL
K821027 · Shiley, Inc. · May 1982
ARGYLE TARTAN TRACHEAL TUBE
K811937 · Sherwood Medical Co. · Jul 1981
LINDHOLM ANATOMICAL TRACHEAL TUBE
K811888 · Mallinckrodt Critical Care · Jul 1981
OHIO DISPOSABLE TRACHEAL TUBE
K800634 · Ohio Medical Products · Apr 1980
FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE
K792035 · Bivona Medical Technologies · Oct 1979
MODEL GV-10 LANZ PRESSURE-VALVE
K791045 · Extracorporeal Medical Specialities, Inc. · Jun 1979