Cleared Traditional

K041044 - CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET

K041044 is an FDA 510(k) clearance for CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTO..., 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 98-day FDA review.

K041044 · Cook, Inc. · Anesthesiology device
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Jul 2004
Decision
98d
Days
Class 2
Risk

K041044 is an FDA 510(k) clearance for the CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET. 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 July 29, 2004 after a review of 98 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 - K041044

510(k) Number K041044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2004
Decision Date July 29, 2004
Days to Decision 98 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
42d faster than avg
Panel avg: 140d · This submission: 98d
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 K041044.
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA
K051416 · Mallinckrodt Medical · Jun 2005
TRACOE PHON ASSIST I - SPEAKING VALVES, REFERENCE MODELS: PHON ASSIST I-650-T/TO AND 650-S/SO
K043160 · Tracoe Medical GmbH · Feb 2005
MARPAC MESSENGER MODEL #501
K041485 · Marpac, Inc. · Aug 2004
PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA
K041348 · Smiths Medical · Jul 2004
SHILEY FLEXTRA TRACHEOSTOMY TUBE
K030787 · Nellcor Puritan Bennett, Inc. · Nov 2003
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
K031057 · Portex, Inc. · Jul 2003