Cleared Traditional

K810575 - MARTIN TRACH-SECURE

K810575 is an FDA 510(k) clearance for MARTIN TRACH-SECURE, manufactured by Diatek, Inc.. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K810575 · Diatek, Inc. · Anesthesiology device
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Mar 1981
Decision
14d
Days
Class 2
Risk

K810575 is an FDA 510(k) clearance for the MARTIN TRACH-SECURE. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Diatek, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1981 after a review of 14 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 Diatek, Inc. devices

FDA 510(k) Submission Details - K810575

510(k) Number K810575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1981
Decision Date March 17, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 140d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTO Device Classification - Class 2, Special Controls

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.

Regulatory Peers - BTO Tube, Tracheostomy (w/wo Connector)

All 63
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K810575.
SHILEY DISPOSABLE CANNULA TRACH. TUBE
K811447 · Shiley, Inc. · Jun 1981
SHILEY LOW PRESSURE THIN-CUFFED TRACH
K811033 · Shiley, Inc. · May 1981
MONTGOMERY SILICONE TRACHEAL T-TUBE
K810978 · Boston Medical Products, Inc. · May 1981
TRACHEOSTOMA VENT
K810436 · Bivona Medical Technologies · Mar 1981
SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE
K810106 · Shiley, Inc. · Feb 1981
MONTG. TRACHEAL CANNULA
K802916 · Boston Medical Products, Inc. · Dec 1980