Cleared Traditional

K810321 - REINFORCED TRACHEOSTOMY TUBE SET(TENTAT) (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K810321 · National Catheter Co. Div. Mallinckrodt · Anesthesiology device
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Mar 1981
Decision
26d
Days
Class 2
Risk

K810321 is an FDA 510(k) clearance for the REINFORCED TRACHEOSTOMY TUBE SET(TENTAT). Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by National Catheter Co. Div. Mallinckrodt (Walker, US). The FDA issued a Cleared decision on March 4, 1981 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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 National Catheter Co. Div. Mallinckrodt devices

Submission Details

510(k) Number K810321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1981
Decision Date March 04, 1981
Days to Decision 26 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 139d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTO Tube, Tracheostomy (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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.