510(k) · Cleared
Recalled · Class I · 2025Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drägerwerk AG & Co. KGaA · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Dec 7, 2022 as substantially equivalent to K202459 (Pharma System AB, 2021) and 2 other predicates after a 167-day review. Its family tree reaches back 7 generations to 1994. 2 of the 26 devices in its family, counting itself, have a Class I recall. It has been recalled 4 times, including 4 Class I recalls.
- Decided
- Dec 7, 2022
- Review
- 167 days
- Class
- Class II
- Product code
- CAH
- Recalls
- 4 (4 Class I)
- Predicates
- 3
Its longest line of descent runs back 7 generations to K941381 (1994). 25 ancestors in all, the oldest K881657 (1988). No later device cites it as a predicate yet. 2 of the 26 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK941381 Hygrobac,S Hygroboy and HygrobabyMallinckrodt Medical · 1994 · Recalled
- 6 generations backK013089 Ems Hepa Filter and Hme CombinationsEngineered Medical Systems · 2002
- 5 generations backK021265 Datex-Ohmeda Hmef 500Datex-Ohmeda · 2002
- 4 generations backK023641 Datex-Ohmeda Hmef MiniDatex-Ohmeda · 2002
- 3 generations backK030990 Datex-Ohmeda Mini-Filter/S and Uni-Filter JuniorDatex-Ohmeda · 2003
- 2 generations backK072002 Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG · 2008 · Recalled (Class I)
- 1 generation backK132709 VR Medical Heat and Moisture Exchanger and FilterVr Medical · 2014
- This deviceK221836 Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022
Class I recalls in this family
- K072002 Filter Carestar 30; Filter Safestar 55…2 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K941381 | Hygrobac,S Hygroboy and Hygrobaby | Mallinckrodt Medical | 1994 | 1 |
| −6 | K013089 | Ems Hepa Filter and Hme Combinations | Engineered Medical Systems | 2002 | — |
| −5 | K021265 | Datex-Ohmeda Hmef 500 | Datex-Ohmeda | 2002 | — |
| −4 | K023641 | Datex-Ohmeda Hmef Mini | Datex-Ohmeda | 2002 | — |
| −3 | K030990 | Datex-Ohmeda Mini-Filter/S and Uni-Filter Junior | Datex-Ohmeda | 2003 | — |
| −2 | K072002 | Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55 | Draeger Medical AG & Co. KG | 2008 | Class I |
| −1 | K132709 | VR Medical Heat and Moisture Exchanger and Filter | Vr Medical | 2014 | — |
| 0 (this device) | K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus | Drägerwerk AG & Co. KGaA | 2022 | — |
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 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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.
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? (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 |
|---|---|---|---|
| * | K202459 | Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME…Summary page 5…Class: II Predicate Device: The Filter CareStar Plus is substantially equivalent to the Bact-Trap from Pharma Systems AB (K202459). The Filter SafeStar Plus is substantially equivalent to the HepaShield Breathing System Filter from Flexicare Medical Limited… | 2021 |
| * | K191909 | HepaShield Bacterial Viral Breathing System FilterSummary page 5…ct-Trap from Pharma Systems AB (K202459). The Filter SafeStar Plus is substantially equivalent to the HepaShield Breathing System Filter from Flexicare Medical Limited (K191909) The Filter/HME TwinStar Plus is substantially equivalent to VR Medical Heat and Moisture Exchanger Filter from VR Medical Techn… | 2020 |
| * | K132709 | VR Medical Heat and Moisture Exchanger and FilterSummary page 5…care Medical Limited (K191909) The Filter/HME TwinStar Plus is substantially equivalent to VR Medical Heat and Moisture Exchanger Filter from VR Medical Technology Co. (K132709). Reference Device (for Filter/HME TwinStar Plus): EMS Electra Filter and Filter/HME (K013122)… | 2014 |
| † | K013122 | Ems Electrostatic Fliter and Hme Combination | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 16, 2025 | Class I | Z-2159-2025 | Process control | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. |
| Jun 16, 2025 | Class I | Z-2158-2025 | Process control | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. |
| Jun 16, 2025 | Class I | Z-2161-2025 | Process control | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. |
| Jun 16, 2025 | Class I | Z-2160-2025 | Process control | Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. |
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 4.6 years on median.
- 4 of the 25 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Filter CareStar Plus Intended use Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use. Indications All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines. They are intended for use in pediatric (with a tidal volume between 100 and 500 ml) and adult patients…
Read the full statement (216 words)
Filter CareStar Plus
Intended use
Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use.
Indications
All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines.
They are intended for use in pediatric (with a tidal volume between 100 and 500 ml) and adult patients, depending on the respective device.
Filter SafeStar Plus
Intended use
Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and respiratory use.
Indications
All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines.
They are intended for use in adult patients.
Filter/HME TwinStar Plus
Intended use
Bidirectionally breathing system filter against bacterial and viral contamination for anesthetic and for respiratory use, as well as heat and moisture exchanger for humidifying respired gases for the patient.
Indications
All devices are intended for single use up to 24 hours and must be used by trained medical personnel only. The devices are designed for use with ventilators and anesthesia machines.
They are intended for use in adult, pediatric and neonatal patients, depending on the respective device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221836 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221836: Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221836
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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