Cleared Special

K014102 - PROVOX HME CASSETTE, MODEL 7240 (FDA 510(k) Clearance)

Also includes:
PROVOX ADHESIVE, MODEL 7251

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K014102 · Atos Medical AB · Anesthesiology device
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Feb 2002
Decision
70d
Days
Class 2
Risk

K014102 is an FDA 510(k) clearance for the PROVOX HME CASSETTE, MODEL 7240. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Atos Medical AB (Horby, SE). The FDA issued a Cleared decision on February 21, 2002 after a review of 70 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Atos Medical AB devices

Submission Details

510(k) Number K014102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2001
Decision Date February 21, 2002
Days to Decision 70 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 139d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

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 108
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K014102.
Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula
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