# K202459: Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter

- Pathway: 510(k) (Traditional)
- Applicant: Pharma System AB
- Decided: Sep 26, 2021 after 395 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K903056 (1990). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903056: Bacttrap, Pharma Systems, Inc. (1990) Summary page 5.
- K903058: Bact-Hme (TM), Pharma Systems, Inc. (1990) Summary page 5.

## Most influential descendants
- K221836: Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (2022), 0 descendants of its own

## Indications for use
Bact Trap 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 anaesthetic or ventilator breathing systems. The Bact Trap filter may either be used on the patient side or on the device side of the ventilator anaesthetic device. The Bact HME/Bact-HME Midi/Pharma Mini is a breathing system filter and a Heat and Moisture Exchanger. The combination ofa 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 Bact HME/Bact-HME Midi/Pharma Mini should be used with patients who have a Tidal Volume between 50 - 1500 ml. The Pharma MiniTmHME/Filter, Bact-HMETm filter/HME and Bact-HMETM Midi HME/Filter should be used with patients who have a Tidal Volume as follows: * Pharma Minim and Bact-Trapm Mini 50-900ml * Bact-HMETM Midi and Bact-Trap~m Midi between 100-1200 ml * Bact-HMETm and Bact-Trap~m between 250-1500 ml The products mentioned above are designed as disposable single patient use and should be changed at least every 24 hours

Source page: https://510kreport.com/device/K202459
Methodology: https://510kreport.com/methodology