Cleared Traditional

K924243 - TRACHEOSTOMY CARE KIT

K924243 is the FDA 510(k) clearance for TRACHEOSTOMY CARE KIT by Transidyne General Corp.. It is a Class 2 Anesthesiology device (product code JOH) cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K924243 · Transidyne General Corp. · Anesthesiology device
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Jun 1993
Decision
296d
Days
Class 2
Risk

K924243 is an FDA 510(k) clearance for the TRACHEOSTOMY CARE KIT. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Transidyne General Corp. (Spartanburg, US). The FDA issued a Cleared decision on June 16, 1993 after a review of 296 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Transidyne General Corp. devices

Submission Details

510(k) Number K924243 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received August 24, 1992
Decision Date June 16, 1993
Days to Decision 296 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 140d · This submission: 296d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOH Tube Tracheostomy And Tube Cuff
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 - JOH Tube Tracheostomy And Tube Cuff

All 58
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K924243.
BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
K944178 · Bivona Medical Technologies · Oct 1994
SALINE SOLUTION-STERILE
K933412 · Trinity Laboratories, Inc. · Oct 1993
TRACHEOSTOMY CARE KIT (STERILE)
K925020 · Customed, Inc. · Jul 1993
BIVONA HYPERFLEX TRACHEOSTOMY TUBE
K922665 · Bivona Medical Technologies · Jan 1993
BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
K923878 · Bivona Medical Technologies · Dec 1992
TRACHEOSTOMY TUBE AND TUBE CUFF
K924660 · Applied Medical Resources · Dec 1992