Cleared Traditional

K980466 - PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

K980466 is an FDA 510(k) clearance for PER-FIT PERCUTANEOUS DILATIONAL TRACHEO..., manufactured by Sims Portex, Inc.. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K980466 · Sims Portex, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
18d
Days
Class 2
Risk

K980466 is an FDA 510(k) clearance for the PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT WITH SPECIALTY TRACHEOSTOMY .... Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Sims Portex, Inc. (Keene, US). The FDA issued a Cleared decision on February 24, 1998 after a review of 18 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 Sims Portex, Inc. devices

FDA 510(k) Submission Details - K980466

510(k) Number K980466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1998
Decision Date February 24, 1998
Days to Decision 18 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
122d faster than avg
Panel avg: 140d · This submission: 18d
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 76
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K980466.
DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA
K970811 · Pneumocare, Inc. · Nov 1998
SHIKANI-FRENCH SPEAKING VALVE
K982128 · Pilling Weck Surgical · Oct 1998
RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET
K972546 · Rusch Intl. · Apr 1998
IRRIGATION BOTTLE
K973829 · Automatic Liquid Packaging, Inc. · Feb 1998
RUSCH TRACHEOFIX-SET
K972423 · Rusch Intl. · Feb 1998
FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED
K972385 · Smiths Industries Medical Systems, Inc. · Jan 1998