Cleared Traditional

PROVOX MICRON HME (K072582) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K072582 · Atos Medical AB · Anesthesiology device
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May 2008
Decision
260d
Days
Class 2
Risk

K072582 is an FDA 510(k) clearance for the PROVOX MICRON HME. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Atos Medical AB (Bonita Springs, US). The FDA issued a Cleared decision on May 30, 2008 after a review of 260 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 Atos Medical AB devices

Submission Details

510(k) Number K072582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2007
Decision Date May 30, 2008
Days to Decision 260 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
120d slower than avg
Panel avg: 140d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K072582.
CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY
K133597 · Cook, Inc. · Apr 2014
SHILEY NEONATAL TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY TUBE CUFFLESS, SHILEY PEDIATRIC TRACHEOSTOMY T
K122531 · Covidien · Oct 2012
CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS
K093469 · Cook, Inc. · Jan 2010
CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER
K072148 · Cook, Inc. · Oct 2007
CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
K041044 · Cook, Inc. · Jul 2004
SHILEY SPECIALIZED TRACHEOSTOMY TUBE
K903435 · Shiley, Inc. · Oct 1990