# K221836: Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus

- Pathway: 510(k) (Traditional)
- Applicant: Drägerwerk AG & Co. KGaA
- Decided: Dec 7, 2022 after 167 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: 4 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K941381 (1994). 25 ancestors in all.
No later device cites it as a predicate yet.
2 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202459: Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter, Pharma System AB (2021) Summary page 5.
- K191909: HepaShield Bacterial Viral Breathing System Filter, Flexicare Medical Limited. (2020) Summary page 5.
- K132709: VR Medical Heat and Moisture Exchanger and Filter, Vr Medical (2014) Summary page 5.

## Recalls of this device
- Jun 16, 2025 · Class I · Z-2159-2025: 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: 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: 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: Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.

## Indications for use
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.

Source page: https://510kreport.com/device/K221836
Methodology: https://510kreport.com/methodology