# K072002: Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical AG & Co. KG
- Decided: Jan 31, 2008 after 192 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K941381 (1994). 18 ancestors in all.
3 later devices descend from it; 2 cite it directly.
2 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031653: Datex-Ohmeda Hmef 750, Datex-Ohmeda (2003) Summary page 2.
- K033008: Air Safety Hepa and Non-Hepa Filters, Air Safety, Ltd. (2004) Summary page 2.
- K030990: Datex-Ohmeda Mini-Filter/S and Uni-Filter Junior, Datex-Ohmeda (2003) Summary page 2.
- K014282: Bacstop Filter,Bacstop Filter/Hme, Munktell Filter AB (2002) Summary page 2.
- K013089: Ems Hepa Filter and Hme Combinations, Engineered Medical Systems (2002) Summary page 2.

## Most influential descendants
- K132709: VR Medical Heat and Moisture Exchanger and Filter (2014), 1 descendant of its own
- K221836: Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (2022), 0 descendants of its own
- K090738: Thermoflo HCH, Thermoflo Filter (2009), 0 descendants of its own

## Recalls of this device
- May 16, 2022 · Class I · Z-1211-2022: Possible occlusion of filters due to manufacturing error.

## Indications for use
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.

Source page: https://510kreport.com/device/K072002
Methodology: https://510kreport.com/methodology