Cleared Traditional

K970365 - PASSY-MUIR O2 ADAPTER

Also marketed or referenced as:
PMA2000

K970365 is an FDA 510(k) clearance for PASSY-MUIR O2 ADAPTER, manufactured by Passy-Muir, Inc.. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K970365 · Passy-Muir, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
12d
Days
Class 2
Risk

K970365 is an FDA 510(k) clearance for the PASSY-MUIR O2 ADAPTER. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Passy-Muir, Inc. (Irvine, US). The FDA issued a Cleared decision on February 12, 1997 after a review of 12 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 Passy-Muir, Inc. devices

FDA 510(k) Submission Details - K970365

510(k) Number K970365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1997
Decision Date February 12, 1997
Days to Decision 12 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d faster than avg
Panel avg: 140d · This submission: 12d
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 62
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K970365.
RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE
K964056 · Rusch Intl. · Oct 1997
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
RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE
K955564 · Rusch, Inc. · Jun 1996
SHILEY CUFFED PEDIATRIC TRACHEOSTOMY TUBE
K955680 · Mallinckrodt Medical · Mar 1996