Cleared Traditional

K133597 - CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY

K133597 is an FDA 510(k) clearance for CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRO..., manufactured by Cook, Inc.. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K133597 · Cook, Inc. · Anesthesiology device
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Apr 2014
Decision
147d
Days
Class 2
Risk

K133597 is an FDA 510(k) clearance for the CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PER.... Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on April 18, 2014 after a review of 147 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 Cook, Inc. devices

FDA 510(k) Submission Details - K133597

510(k) Number K133597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2013
Decision Date April 18, 2014
Days to Decision 147 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 140d · This submission: 147d
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 88
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K133597.
Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard Cuff
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H&H EMERGENCY CRICOTHYROTOMY KIT
K133528 · H & H Medical Corporation · Jul 2014
RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET
K133173 · Teleflexmedical, Inc. · May 2014
SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
K122932 · Fogless International AB · Dec 2013
RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
K122235 · Teleflexmedical, Inc. · Sep 2013
FAHL TRACHEOSTOMY TUBES (MULTIPLE)
K123699 · Andreas Fahl Medizintechnik-Vertrieb GmbH · Aug 2013