Cleared Traditional

K921733 - TRACHEOSTOMY CARE TRAY

K921733 is an FDA 510(k) clearance for TRACHEOSTOMY CARE TRAY, manufactured by Medikmark, Inc.. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 796-day FDA review.

K921733 · Medikmark, Inc. · Anesthesiology device
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Jun 1994
Decision
796d
Days
Class 2
Risk

K921733 is an FDA 510(k) clearance for the TRACHEOSTOMY CARE TRAY. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Medikmark, Inc. (Chicago, US). The FDA issued a Cleared decision on June 15, 1994 after a review of 796 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.

View all Medikmark, Inc. devices

FDA 510(k) Submission Details - K921733

510(k) Number K921733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 10, 1992
Decision Date June 15, 1994
Days to Decision 796 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
656d slower than avg
Panel avg: 140d · This submission: 796d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOH Device Classification - Class 2, Special Controls

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 90
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K921733.
MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE
K945513 · Mallinckrodt Medical · Jan 1995
EUROMEDICAL POLY TRACHEOTOMY TUBE
K945874 · Regulatory & Marketing Services, Inc. · Dec 1994
BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
K944178 · Bivona Medical Technologies · Oct 1994
PERCUTANEOUS TRACHEOSTOMY KIT
K936133 · Smiths Industries Medical Systems, Inc. · Mar 1994
TRACHEOSTOMY CARE TRAY
K932016 · Clinipad Corp. · Nov 1993
SALINE SOLUTION-STERILE
K933412 · Trinity Laboratories, Inc. · Oct 1993