Cleared Traditional

K041348 - PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA

K041348 is an FDA 510(k) clearance for PORTEX ULTRAPERC PERCUTANEOUS DILATION ..., manufactured by Smiths Medical. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K041348 · Smiths Medical · Anesthesiology device
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Jul 2004
Decision
54d
Days
Class 2
Risk

K041348 is an FDA 510(k) clearance for the PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS .... Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Smiths Medical (Hythe, Kent, GB). The FDA issued a Cleared decision on July 13, 2004 after a review of 54 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smiths Medical devices

FDA 510(k) Submission Details - K041348

510(k) Number K041348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2004
Decision Date July 13, 2004
Days to Decision 54 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
86d faster than avg
Panel avg: 140d · This submission: 54d
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 K041348.
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