Cleared Traditional

K931611 - PERCUTANEOUS TRACHEOSTOMY TUBE KIT

K931611 is an FDA 510(k) clearance for PERCUTANEOUS TRACHEOSTOMY TUBE KIT, manufactured by Crandall Medical Devices. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K931611 · Crandall Medical Devices · Anesthesiology device
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Aug 1993
Decision
148d
Days
Class 2
Risk

K931611 is an FDA 510(k) clearance for the PERCUTANEOUS TRACHEOSTOMY TUBE KIT. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Crandall Medical Devices (Costa Mesa, US). The FDA issued a Cleared decision on August 27, 1993 after a review of 148 days - within the typical 510(k) review window.

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 Crandall Medical Devices devices

FDA 510(k) Submission Details - K931611

510(k) Number K931611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received April 01, 1993
Decision Date August 27, 1993
Days to Decision 148 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
8d slower than avg
Panel avg: 140d · This submission: 148d
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 98
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K931611.
TRACHEOSTOMY CARE TRAY
K932016 · Clinipad Corp. · Nov 1993
SALINE SOLUTION-STERILE
K933412 · Trinity Laboratories, Inc. · Oct 1993
TRACHEOSTOMY KIT
K925288 · Ajs Medical Co., Inc. · Aug 1993
TRACHEOSTOMY CARE TRAY
K923156 · Orion Life Systems, Inc. · Aug 1993
TRACHEOSTOMY CARE KIT (STERILE)
K925020 · Customed, Inc. · Jul 1993
SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF
K930895 · Mallinckrodt Medical Tpi, Inc. · Jul 1993