510(k) · Cleared
ClearedFilterflo Hepa; Thermoflo Hepa (Filter / Hme)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arc Medical, Inc. · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Apr 13, 2007 after a 182-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Apr 13, 2007
- Review
- 182 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK063125 Filterflo Hepa; Thermoflo Hepa (Filter / Hme)Arc Medical, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK120079 Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH · 2012
- Descendant · 2 generations on · 1 of its ownK123699 Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH · 2013
- Descendant · 3 generations on · 0 of its ownK233713 Pilling Tracheostomy TubesTeleflex Medical · 2024
- Descendant · cites it directly · 0 of its ownK093426 Bact-Trap Hepa MidiPharma Systems AB · 2010
- Descendant · cites it directly · 0 of its ownK083702 Trach-AssistMergenet Medical · 2009
Most influential descendants
Showing 5 of 5 · See all- K120079Primed Tracheostomy Tubes (Multiple)Primed Halberstadt Medizintechnik GmbH · 2012 · cites it directly2descendants
- K123699Fahl Tracheostomy Tubes (Multiple)Andreas Fahl Medizintechnik-Vertrieb GmbH · 2013 · 2 generations on1descendant
- K233713Pilling Tracheostomy TubesTeleflex Medical · 2024 · 3 generations on0descendants
- K093426Bact-Trap Hepa MidiPharma Systems AB · 2010 · cites it directly0descendants
- K083702Trach-AssistMergenet Medical · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063125 | Filterflo Hepa; Thermoflo Hepa (Filter / Hme) | Arc Medical, Inc. | 2007 | — |
| +1 | K120079 | Primed Tracheostomy Tubes (Multiple) | Primed Halberstadt Medizintechnik GmbH | 2012 | — |
| +2 | K123699 | Fahl Tracheostomy Tubes (Multiple) | Andreas Fahl Medizintechnik-Vertrieb GmbH | 2013 | — |
| +3 | K233713 | Pilling Tracheostomy Tubes | Teleflex Medical | 2024 | — |
| +1 | K093426 | Bact-Trap Hepa Midi | Pharma Systems AB | 2010 | — |
| +1 | K083702 | Trach-Assist | Mergenet Medical | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAH? 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 CAH device
- #1 K251583 Ambu® Virobac II® Exhalation Filterscore 11.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 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?
- Of its descendants, K120079 (Primed Halberstadt Medizintechnik GmbH, 2012) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CAH
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CAH
237in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAH
1in 2025
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · CAH
77in 2025
MAUDE reports naming product code CAH, 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 | 2 | — | 0 | 32 |
| 2008 | 1 | — | 0 | 27 |
| 2009 | 4 | 111 | 0 | 18 |
| 2010 | 5 | 216 | 2 | 40 |
| 2011 | 3 | 281 | 0 | 9 |
| 2012 | 3 | 212 | 0 | 16 |
| 2013 | 1 | — | 1 | 47 |
| 2014 | 4 | 250 | 1 | 98 |
| 2015 | 2 | — | 0 | 51 |
| 2016 | 0 | — | 0 | 34 |
| 2017 | 1 | — | 1 | 29 |
| 2018 | 0 | — | 0 | 33 |
| 2019 | 2 | — | 0 | 30 |
| 2020 | 2 | — | 0 | 33 |
| 2021 | 2 | — | 0 | 56 |
| 2022 | 3 | 204 | 6 (6) | 67 |
| 2023 | 3 | 237 | 0 | 40 |
| 2024 | 2 | — | 0 | 51 |
| 2025 | 0 | — | 1 (1) | 77 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K063125 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063125: Filterflo Hepa; Thermoflo Hepa (Filter / Hme).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063125
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026