510(k) Report

510(k) · Cleared

Cleared

Provox Micron Hme

K072582510(k) TraditionalCleared May 30, 2008260-day reviewClass II21 CFR 868.5800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Atos Medical AB · JOH Tube Tracheostomy And Tube Cuff

Cleared on May 30, 2008 as substantially equivalent to K014102 (Atos Medical AB, 2002) and 3 other predicates after a 260-day review. Its family tree reaches back 6 generations to 1994.

Decided
May 30, 2008
Review
260 days
Class
Class II
Product code
JOH
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K941381 (1994). 19 ancestors in all, the oldest K821568 (1982). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 2 other ancestors1992: 1 other ancestor1999: 1 other ancestor1985: 1 other ancestor1982: 1 other ancestor1994: 3 other ancestors1996: 1 other ancestor2001: 3 other ancestorsK941381 · Hygrobac,S Hygroboy and Hygrobaby · Mallinckrodt Medical · 1994 · recalledK013089 · Ems Hepa Filter and Hme Combinations · Engineered Medical Systems · 2002×2: 2 generations cleared close together, K021265 (2002), K023641 (2002) K030990 · Datex-Ohmeda Mini-Filter/S and Uni-Filter Junior · Datex-Ohmeda · 2003K043120 · Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-Filter · Datex-Ohmeda, Inc. · 20051980198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 3 other ancestors3 generations back: 1 other ancestor5 generations back: 1 other ancestor6 generations back: 5 other ancestors K043120 · Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-Filter · Datex-Ohmeda, Inc. · 2005K030990 · Datex-Ohmeda Mini-Filter/S and Uni-Filter Junior · Datex-Ohmeda · 2003K023641 · Datex-Ohmeda Hmef Mini · Datex-Ohmeda · 2002K021265 · Datex-Ohmeda Hmef 500 · Datex-Ohmeda · 2002K013089 · Ems Hepa Filter and Hme Combinations · Engineered Medical Systems · 2002K941381 · Hygrobac,S Hygroboy and Hygrobaby · Mallinckrodt Medical · 1994 · recalled−50
  1. Root · 6 generations backK941381 Hygrobac,S Hygroboy and HygrobabyMallinckrodt Medical · 1994 · Recalled
  2. 5 generations backK013089 Ems Hepa Filter and Hme CombinationsEngineered Medical Systems · 2002
  3. 4 generations backK021265 Datex-Ohmeda Hmef 500Datex-Ohmeda · 2002
  4. 3 generations backK023641 Datex-Ohmeda Hmef MiniDatex-Ohmeda · 2002
  5. 2 generations backK030990 Datex-Ohmeda Mini-Filter/S and Uni-Filter JuniorDatex-Ohmeda · 2003
  6. 1 generation backK043120 Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-FilterDatex-Ohmeda, Inc. · 2005
  7. This deviceK072582 Provox Micron HmeAtos Medical AB · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K941381Hygrobac,S Hygroboy and HygrobabyMallinckrodt Medical19941
−5K013089Ems Hepa Filter and Hme CombinationsEngineered Medical Systems2002—
−4K021265Datex-Ohmeda Hmef 500Datex-Ohmeda2002—
−3K023641Datex-Ohmeda Hmef MiniDatex-Ohmeda2002—
−2K030990Datex-Ohmeda Mini-Filter/S and Uni-Filter JuniorDatex-Ohmeda2003—
−1K043120Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-FilterDatex-Ohmeda, Inc.2005—
0 (this device)K072582Provox Micron HmeAtos Medical AB2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198210
198510
199210
199430
199610
199910
200130
200220
FIG. 1 — Lineage of K072582, 1994–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JOH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JOH device

  1. #1 K251313 Shiley™ Adult Flexible Tracheostomy Tube XLT…score 11.2 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K014102Provox Hme Cassette, Model 7240; Provox Adhesive, Model 7251
Summary page 2
…re settings, and home Contraindications: None Summary of substantial equivalence Predicates Provox® HME Cassette (K014102) Specification Provox® FreeHands HME (K022125) Proposed Device Blom Singer HME…
Atos Medical AB2002—
*K022125Provox Freehands Hme, Model 7710
Summary page 1
…Provox® Micron HMETM Predicate Devices: Atos - Provox® H ME systemn- KO014102 Atos - Provox® FreeHands HME - K022 125 In Health Blomn Singer HME systems - K91 5786 Draeger - Uni-F…
Atos Medical AB2002—
*K915786Blom-Singer Humid/Fil Syst Inhealth in-Line Humid.
Summary page 1
…® H ME systemn- KO014102 Atos - Provox® FreeHands HME - K022 125 In Health Blomn Singer HME systems - K91 5786 Draeger - Uni-Filter - K043 120 Device Description: The Provox®W Micron H~~METM is a device w…
Helix Medical, Inc.1992—
*K043120Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-Filter
Summary page 1
…Provox® FreeHands HME - K022 125 In Health Blomn Singer HME systems - K91 5786 Draeger - Uni-Filter - K043 120 Device Description: The Provox®W Micron H~~METM is a device which covers thle stomna of a laryngectomny patient. It is designed…
Datex-Ohmeda, Inc.2005—

Also cleared against K014102: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
  • 4 of the 19 ancestors have a recall of any class.
  • 1 other device also cites its predicate K014102.

How does its category compare?

All JOH devices

JOH Tube Tracheostomy And Tube Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · JOH

1in 2025

2007: 12008: 22009: 12010: 22012: 12013: 32014: 32015: 32016: 12017: 12018: 32019: 22020: 12021: 22025: 1
2007high 3 (2013) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOH

137in 2018

2013: 407 days median2014: 218 days median2015: 179 days median2018: 137 days median
2007high 407 (2013) · low 137 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JOH

1in 2023

2007: 12009: 12010: 732011: 42016: 2, 1 Class I2020: 12023: 12026 (partial year): 1
2007high 73 (2010) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · JOH

986in 2025

2007: 1672008: 1022009: 1952010: 1,2702011: 5872012: 5002013: 5442014: 5062015: 5082016: 5722017: 4412018: 8122019: 1,0192020: 7912021: 1,0412022: 1,6322023: 1,2332024: 1,1032025: 986
2007high 1,632 (2022) · low 102 (2008)2025

MAUDE reports naming product code JOH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—1167
20082—0102
20091—1195
20102—731,270
20110—4587
20121—0500
201334070544
201432180506
201531790508
20161—2 (1)572
20171—0441
201831370812
20192—01,019
20201—1791
20212—01,041
20220—01,632
20230—11,233
20240—01,103
20251—0986
20260—1—

What is it indicated for?

The Provox® Micron HMETM is a specialized stoma cover that acts as a heat and moisture exchanger (HME) and air filtration device for laryngectomized patients. Provox® Micron HMETM partially restores lost breathing resistance due to laryngectomy.

For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.

It is intended to be used with the Provox®HME System.

Environments of use include - hospitals, sub-acute care institutions and home.

Indications for use as stated in the FDA summary.

Also cleared against K014102

1 other device cites the same predicate.

  • K022125Provox Freehands Hme, Model 7710Atos Medical AB · 2002

More from Atos Medical AB

15 FDA decisions under this applicant name. See the company

  • K151404ProTrach DualcareAtos Medical AB · 2016
  • K141380Provox Freehands FlexivoiceAtos Medical AB · 2014
  • K131947Provox Vega Puncture SetAtos Medical AB · 2013
  • K092593Provox Activalve (Size 4.5MM, 6MM, 8MM, 10MM, 12.5MM)Atos Medical AB · 2010
  • K090455Provox Vega, Model 8130-8135Atos Medical AB · 2009

Recent decisions in JOH

The JOH category page

  • K251313Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula…Covidien, LLC · 2025
  • K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra…Smiths Medical Asd, Inc. · 2021
  • K203362TRACOE varioTracoe Medical GmbH · 2021
  • K193077Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffCovidien · 2020
  • K193133Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy…Cook Incorporated · 20192 Class I recalls

https://510kreport.com/device/K072582 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072582: Provox Micron Hme.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072582

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026