510(k) · Cleared
ClearedThermoflo HCH, Thermoflo Filter
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 Jul 27, 2009 as substantially equivalent to K903056 (Pharma Systems, Inc., 1990) and 2 other predicates after a 129-day review. Its family tree reaches back 6 generations to 1994. 1 of the 22 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 27, 2009
- Review
- 129 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K941381 (1994). 21 ancestors in all, the oldest K881657 (1988). No later device cites it as a predicate yet. 1 of the 22 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK941381 Hygrobac,S Hygroboy and HygrobabyMallinckrodt Medical · 1994 · Recalled
- 5 generations backK013089 Ems Hepa Filter and Hme CombinationsEngineered Medical Systems · 2002
- 4 generations backK021265 Datex-Ohmeda Hmef 500Datex-Ohmeda · 2002
- 3 generations backK023641 Datex-Ohmeda Hmef MiniDatex-Ohmeda · 2002
- 2 generations backK030990 Datex-Ohmeda Mini-Filter/S and Uni-Filter JuniorDatex-Ohmeda · 2003
- 1 generation backK072002 Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG · 2008 · Recalled (Class I)
- This deviceK090738 Thermoflo HCH, Thermoflo FilterArc Medical, Inc. · 2009
Class I recalls in this family
- K072002 Filter Carestar 30; Filter Safestar 55…direct predicate · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941381 | Hygrobac,S Hygroboy and Hygrobaby | Mallinckrodt Medical | 1994 | 1 |
| −5 | K013089 | Ems Hepa Filter and Hme Combinations | Engineered Medical Systems | 2002 | — |
| −4 | K021265 | Datex-Ohmeda Hmef 500 | Datex-Ohmeda | 2002 | — |
| −3 | K023641 | Datex-Ohmeda Hmef Mini | Datex-Ohmeda | 2002 | — |
| −2 | K030990 | Datex-Ohmeda Mini-Filter/S and Uni-Filter Junior | Datex-Ohmeda | 2003 | — |
| −1 | K072002 | Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55 | Draeger Medical AG & Co. KG | 2008 | Class I |
| 0 (this device) | K090738 | Thermoflo HCH, Thermoflo Filter | Arc Medical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K903056 | BacttrapSummary page 1…er Device: FilterFloTM filter TherrmoFlJoT M filter/HME Predicate Devices: Pharmna Systems - K903 056 - Bact Trap filters Pharmia Systemns - K903 058 - Bact HME Dr… | 1990 |
| * | K903058 | Bact-Hme (TM)Summary page 1…TherrmoFlJoT M filter/HME Predicate Devices: Pharmna Systems - K903 056 - Bact Trap filters Pharmia Systemns - K903 058 - Bact HME Dragrer - K072002 - Care Star 30 and Twin Star 55 Device Description: The ARC Medic… | 1990 |
| * | K072002 | Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Summary page 1…Pharmna Systems - K903 056 - Bact Trap filters Pharmia Systemns - K903 058 - Bact HME Dragrer - K072002 - Care Star 30 and Twin Star 55 Device Description: The ARC Medical filter and filter /H-ME are standard breathing circuit filte… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K072002Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG · 2008 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 21 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K903056.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 | — |
What is it indicated for?
FilterFloTM filter is a breathing system filter which is designed to reduce possible airborne or liquid-borne cross contamination With micro-organisms and particulate matter via anesthetic or ventilator breathing systems. The FilterFloTM filter may either be used on the patient side or on the device side of the ventilator / anesthetic device and is used as a hygienic measure alternatively to decontamination of breathing system and / or breathing gas…
Read the full statement (206 words)
FilterFloTM filter is a breathing system filter which is designed to reduce possible airborne or liquid-borne cross contamination With micro-organisms and particulate matter via anesthetic or ventilator breathing systems.
The FilterFloTM filter may either be used on the patient side or on the device side of the ventilator / anesthetic device and is used as a hygienic measure alternatively to decontamination of breathing system and / or breathing gas conveying parts of the ventilator.
The ThermoFloTM filter/HME is a breathing system filter and a Heat and Moisture Exchanger. The combination of a filter and a Heat and Moisture Exchanger offer the benefit of both product features. Heat and Moisture Exchangers are used as a conditioning system for mechanically ventilated patients whose upper airways are bypassed. In almost all cases of mechanical ventilation they are a fully valid alternative to heated humidifiers. The product is the only conditioning opportunity of breathing gases in cases of emergency ventilation or during transport since heated humidified are almost impossible to use. The ThermoFlo TM filter/HME should be used with patients who have a Tidal Volume between 250 - 1500 ml.
The products mentioned above are designed as disposable single patient use and should be changed at least every 24 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090738: Thermoflo HCH, Thermoflo Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090738
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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