Cleared Traditional

K850456 - TRACHEOSTOMY CARE KIT

K850456 is an FDA 510(k) clearance for TRACHEOSTOMY CARE KIT, manufactured by Excel Health Care Products. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K850456 · Excel Health Care Products · Anesthesiology device
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Mar 1985
Decision
33d
Days
Class 2
Risk

K850456 is an FDA 510(k) clearance for the TRACHEOSTOMY CARE KIT. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Excel Health Care Products (S. Plainfield, US). The FDA issued a Cleared decision on March 11, 1985 after a review of 33 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 Excel Health Care Products devices

FDA 510(k) Submission Details - K850456

510(k) Number K850456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1985
Decision Date March 11, 1985
Days to Decision 33 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 140d · This submission: 33d
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 73
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K850456.
CLEANING KIT CARE & CLEANING OF TRACHEAL T-TUBE
K853419 · Hood Laboratories · Dec 1985
LGT TUBE
K852413 · Mallinckrodt Critical Care · Sep 1985
BIVONA TRACHEOSTOMA VALVE II
K852272 · Bivona Medical Technologies · Jul 1985
SHILEY DISPOS. CANNULA FENESTRATED LOW
K843729 · Shiley, Inc. · Oct 1984
SHILEY DISPOS. DECANNULATION PLUG W/SW/
K843730 · Shiley, Inc. · Oct 1984
3-DAY BIOINDICATOR RELEASE FOR RESPIR
K833832 · Shiley, Inc. · Mar 1984