Cleared Traditional

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

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

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

Submitted by Atos Medical AB (Bonita Springs, US). The FDA issued a Cleared decision on May 30, 2008, 260 days after receiving the submission on September 13, 2007.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K072582 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code JOH — Tube Tracheostomy And Tube Cuff
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5800

Similar Devices — JOH Tube Tracheostomy And Tube Cuff

All 108
Shiley? Adult Flexible Tracheostomy Tube XLT with TaperGuard? Cuff, Distal with Disposable Inner Cannula; Shiley? Adult Flexible Tracheostomy Tube XLT with TaperGuard? Cuff, Proximal with Disposable Inner Cannula; Shiley? Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley? Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley? Adult Flexible Disposable Inner Cannula XLT
K251313 · Covidien, LLC · Dec 2025
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
K210833 · Smiths Medical Asd, Inc. · Nov 2021
TRACOE vario
K203362 · Tracoe Medical GmbH · Aug 2021
Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
K193077 · Covidien · Jun 2020
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
K193133 · Cook Incorporated · Dec 2019
Shiley Neonatal/Pediatric Tracheostomy Tube
K182861 · Covidien · Mar 2019