510(k) · Cleared
Recalled · Class I · 2022Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical AG & Co. KG · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Jan 31, 2008 as substantially equivalent to K031653 (Datex-Ohmeda, 2003) and 4 other predicates after a 192-day review. Its family tree reaches back 5 generations to 1994. 2 of the 22 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Jan 31, 2008
- Review
- 192 days
- Class
- Class II
- Product code
- CAH
- Recalls
- 1 (1 Class I)
- Predicates
- 5
Its longest line of descent runs back 5 generations to K941381 (1994). 18 ancestors in all, the oldest K881657 (1988). 3 later devices descend from it, 2 citing it directly. 2 of the 22 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK941381 Hygrobac,S Hygroboy and HygrobabyMallinckrodt Medical · 1994 · Recalled
- 4 generations backK013089 Ems Hepa Filter and Hme CombinationsEngineered Medical Systems · 2002
- 3 generations backK021265 Datex-Ohmeda Hmef 500Datex-Ohmeda · 2002
- 2 generations backK023641 Datex-Ohmeda Hmef MiniDatex-Ohmeda · 2002
- 1 generation backK030990 Datex-Ohmeda Mini-Filter/S and Uni-Filter JuniorDatex-Ohmeda · 2003
- This deviceK072002 Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG · 2008
- Descendant · cites it directly · 1 of its ownK132709 VR Medical Heat and Moisture Exchanger and FilterVr Medical · 2014
- Descendant · 2 generations on · 0 of its ownK221836 Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK090738 Thermoflo HCH, Thermoflo FilterArc Medical, Inc. · 2009
Class I recalls in this family
- K221836 Filter CareStar Plus, Filter SafeStar Plus…2 generations on · 2022
Most influential descendants
Showing 3 of 3 · See all- K132709VR Medical Heat and Moisture Exchanger and FilterVr Medical · 2014 · cites it directly1descendant
- K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · 2 generations on0descendants
- K090738Thermoflo HCH, Thermoflo FilterArc Medical, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941381 | Hygrobac,S Hygroboy and Hygrobaby | Mallinckrodt Medical | 1994 | 1 |
| −4 | K013089 | Ems Hepa Filter and Hme Combinations | Engineered Medical Systems | 2002 | — |
| −3 | K021265 | Datex-Ohmeda Hmef 500 | Datex-Ohmeda | 2002 | — |
| −2 | K023641 | Datex-Ohmeda Hmef Mini | Datex-Ohmeda | 2002 | — |
| −1 | K030990 | Datex-Ohmeda Mini-Filter/S and Uni-Filter Junior | Datex-Ohmeda | 2003 | — |
| 0 (this device) | K072002 | Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55 | Draeger Medical AG & Co. KG | 2008 | — |
| +1 | K132709 | VR Medical Heat and Moisture Exchanger and Filter | Vr Medical | 2014 | — |
| +2 | K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus | Drägerwerk AG & Co. KGaA | 2022 | Class I |
| +1 | 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 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2022 | 1 | 1 |
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.
2 devices in this family have 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? (5)
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 |
|---|---|---|---|
| * | K031653 | Datex-Ohmeda Hmef 750Summary page 2…(73CAH) 868.5375 Heat and moisture condenser (artificial nose) (73BYD) Legally Marketed Device to which Substantial Equivalence is claimed: K031653 Datex-Ohmeda HMEF 750 Datex-Ohmeda K033008 Air Safety HEPA and non-HEPA Fil… | 2003 |
| * | K033008 | Air Safety Hepa and Non-Hepa FiltersSummary page 2…se) (73BYD) Legally Marketed Device to which Substantial Equivalence is claimed: K031653 Datex-Ohmeda HMEF 750 Datex-Ohmeda K033008 Air Safety HEPA and non-HEPA Filters AirSafety K030990 Datex-Ohmeda Mini-Filter/S… | 2004 |
| * | K030990 | Datex-Ohmeda Mini-Filter/S and Uni-Filter JuniorSummary page 2…K031653 Datex-Ohmeda HMEF 750 Datex-Ohmeda K033008 Air Safety HEPA and non-HEPA Filters AirSafety K030990 Datex-Ohmeda Mini-Filter/S Datex-Ohmeda Datex-Ohmeda Uni-Filter Junior… | 2003 |
| * | K014282 | Bacstop Filter,Bacstop Filter/HmeSummary page 2…A Filters AirSafety K030990 Datex-Ohmeda Mini-Filter/S Datex-Ohmeda Datex-Ohmeda Uni-Filter Junior K014282 Bacstop, Bacstop mini, Bacstop Humini Munktell K013089 EMS HEPA Filter… | 2002 |
| * | K013089 | Ems Hepa Filter and Hme CombinationsSummary page 2…Datex-Ohmeda Datex-Ohmeda Uni-Filter Junior K014282 Bacstop, Bacstop mini, Bacstop Humini Munktell K013089 EMS HEPA Filter EMS Device Description: The filters CareStar 30 and SafeStar 55 a… | 2002 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2022 | Class I | Z-1211-2022 | Process design | Possible occlusion of filters due to manufacturing error. |
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.
- K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · 2 generations on · ◆ in the 2022 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K132709 (Vr Medical, 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K031653.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
CareStar 30 and SafeStar 55 are Breathing System Filters which are designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anaesthetic or ventilator breathing systems. The products may either be used on the patient side or on the device side of the ventilator/ anaesthetic device and are used as a hygienic measure alternatively to decontamination of breathing system and/or breathing gas…
Read the full statement (182 words)
CareStar 30 and SafeStar 55 are Breathing System Filters which are designed to reduce
possible airborne or liquid-borne cross contamination with micro-organisms and particulate
matter via anaesthetic or ventilator breathing systems.
The products may either be used on the patient side or on the device side of the ventilator/
anaesthetic device and are used as a hygienic measure alternatively to decontamination of
breathing system and/or breathing gas conveying parts of the ventilator.
TwinStar 55 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 Exchanger 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 products are the only
conditioning opportunity of breathing gases in cases of emergency ventilation or during
transport since Heated Humidifiers are almost impossible to use.
The products mentioned above are designed for disposable use and should be changed at
least every 24 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072002: Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072002
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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