510(k) · Cleared
ClearedProvox Freehands Hme, Model 7710
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atos Medical AB · EWL Prosthesis, Laryngeal (Taub)
Cleared on Jul 30, 2002 as substantially equivalent to K014102 (Atos Medical AB, 2002) and 2 other predicates after a 29-day review. Its family tree reaches back 1 generation to 1982. 2 later devices descend from it.
- Decided
- Jul 30, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- EWL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K821568 (1982). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK821568 Blow-Singer Tracheostoma ValveBivona Medical Technologies · 1982 · Recalled
- This deviceK022125 Provox Freehands Hme, Model 7710Atos Medical AB · 2002
- Descendant · cites it directly · 0 of its ownK141380 Provox Freehands FlexivoiceAtos Medical AB · 2014
- Descendant · cites it directly · 0 of its ownK072582 Provox Micron HmeAtos Medical AB · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K821568 | Blow-Singer Tracheostoma Valve | Bivona Medical Technologies | 1982 | 1 |
| 0 (this device) | K022125 | Provox Freehands Hme, Model 7710 | Atos Medical AB | 2002 | — |
| +1 | K141380 | Provox Freehands Flexivoice | Atos Medical AB | 2014 | — |
| +1 | K072582 | Provox Micron Hme | Atos Medical AB | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
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 EWL? 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 EWL device
- #1 K240763 FirstFit Surgical Kitscore 9.1 · 3 generations · no Class I recall
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K014102 | Provox Hme Cassette, Model 7240; Provox Adhesive, Model 7251 | 2002 |
| * | K821568 | Blow-Singer Tracheostoma ValveSummary page 1…Blom-Singer Adjustable Tracheostoma Valve with HumidiFilter Cap 510(k) Number: K82 1568 Inhealth Technologies, USA BivonaTMTracheostoma Valve I1… | 1982 |
| * | K852272 | Bivona Tracheostoma Valve IISummary page 1…1568 Inhealth Technologies, USA BivonaTMTracheostoma Valve I1 510(k) Number: K852272 Bivona Medical Technologies, USA Intended Use The ProvoxB FreeHands system is a hea… | 1985 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All EWL devicesEWL Prosthesis, Laryngeal (Taub): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EWL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · EWL
Too few EWL 510(k)s in any year since 2007 to give a median.
Recalls per year · EWL
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EWL
12in 2025
MAUDE reports naming product code EWL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 21 |
| 2008 | 1 | — | 0 | 10 |
| 2009 | 1 | — | 0 | 6 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 1 | — | 1 | 5 |
| 2014 | 1 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 11 |
| 2016 | 0 | — | 0 | 16 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Provox FreeHands system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and moist from exhaled air in the device. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022125 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022125: Provox Freehands Hme, Model 7710.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022125
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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