Cleared Traditional

K925020 - TRACHEOSTOMY CARE KIT (STERILE)

K925020 is an FDA 510(k) clearance for TRACHEOSTOMY CARE KIT (STERILE), manufactured by Customed, Inc.. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K925020 · Customed, Inc. · Anesthesiology device
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Jul 1993
Decision
286d
Days
Class 2
Risk

K925020 is an FDA 510(k) clearance for the TRACHEOSTOMY CARE KIT (STERILE). Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on July 7, 1993 after a review of 286 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 Customed, Inc. devices

FDA 510(k) Submission Details - K925020

510(k) Number K925020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received September 24, 1992
Decision Date July 07, 1993
Days to Decision 286 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 140d · This submission: 286d
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 71
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K925020.
PERCUTANEOUS TRACHEOSTOMY KIT
K936133 · Smiths Industries Medical Systems, Inc. · Mar 1994
SALINE SOLUTION-STERILE
K933412 · Trinity Laboratories, Inc. · Oct 1993
TRACHEOSTOMY CARE TRAY
K923156 · Orion Life Systems, Inc. · Aug 1993
TRACHEOSTOMY CARE KIT
K924243 · Transidyne General Corp. · Jun 1993
BIVONA HYPERFLEX TRACHEOSTOMY TUBE
K922665 · Bivona Medical Technologies · Jan 1993
BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
K923878 · Bivona Medical Technologies · Dec 1992