Cleared Traditional

K822440 - PERCUTANEOUS CRICOTHYROIDOTOMY

K822440 is an FDA 510(k) clearance for PERCUTANEOUS CRICOTHYROIDOTOMY, manufactured by Frederic J. Toye, M.D.. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 794-day FDA review.

K822440 · Frederic J. Toye, M.D. · Anesthesiology device
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Oct 1984
Decision
794d
Days
Class 2
Risk

K822440 is an FDA 510(k) clearance for the PERCUTANEOUS CRICOTHYROIDOTOMY. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Frederic J. Toye, M.D. (Mchenry, US). The FDA issued a Cleared decision on October 15, 1984 after a review of 794 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

FDA 510(k) Submission Details - K822440

510(k) Number K822440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1982
Decision Date October 15, 1984
Days to Decision 794 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
654d slower than avg
Panel avg: 140d · This submission: 794d
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 85
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K822440.
BIVONA TRACHEOSTOMA VALVE II
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K843730 · Shiley, Inc. · Oct 1984
3-DAY BIOINDICATOR RELEASE FOR RESPIR
K833832 · Shiley, Inc. · Mar 1984
DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY
K840539 · Shiley, Inc. · Mar 1984
H.R. JAKOBI SURG. INSTRUMENTS #9 48
K834179 · Imm Enterprises , Ltd. · Jan 1984