# K090738: Thermoflo HCH, Thermoflo Filter

- Pathway: 510(k) (Traditional)
- Applicant: Arc Medical, Inc.
- Decided: Jul 27, 2009 after 129 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: 6 generations back to K941381 (1994). 21 ancestors in all.
No later device cites it as a predicate yet.
1 of 22 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 1.
- K903058: Bact-Hme (TM), Pharma Systems, Inc. (1990) Summary page 1.
- K072002: Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55, Draeger Medical AG & Co. KG (2008) Summary page 1.

## Indications for use
FilterFloTM 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 anesthetic or ventilator breathing systems. The FilterFloTM filter may either be used on the patient side or on the device side of the ventilator / anesthetic device and is used as a hygienic measure alternatively to decontamination of breathing system and / or breathing gas conveying parts of the ventilator. The ThermoFloTM filter/HME 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 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 product is the only conditioning opportunity of breathing gases in cases of emergency ventilation or during transport since heated humidified are almost impossible to use. The ThermoFlo TM filter/HME should be used with patients who have a Tidal Volume 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/K090738
Methodology: https://510kreport.com/methodology