Cleared Traditional

K955564 - RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET

K955564 is an FDA 510(k) clearance for RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, manufactured by Rusch, Inc.. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K955564 · Rusch, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jun 1996
Decision
205d
Days
Class 2
Risk

K955564 is an FDA 510(k) clearance for the RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Rusch, Inc. (Jeffrey, US). The FDA issued a Cleared decision on June 28, 1996 after a review of 205 days - an extended review 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: 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 Rusch, Inc. devices

FDA 510(k) Submission Details - K955564

510(k) Number K955564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1995
Decision Date June 28, 1996
Days to Decision 205 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
65d slower than avg
Panel avg: 140d · This submission: 205d
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 60
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K955564.
SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF
K971267 · Mallinckrodt Medical · Sep 1997
PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA
K963732 · Mallinckrodt Medical · Jun 1997
SHIKEY TRACHEOSTOMY TUBES AND ACCESSORIES
K962173 · Mallinckrodt Medical · Oct 1996
SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE
K955680 · Mallinckrodt Medical · Mar 1996
MALLINCKRODT SHILEY 15MM CAP
K954749 · Mallinckrodt Medical · Jan 1996
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
K955516 · Boston Medical Products, Inc. · Dec 1995