# K163300: ThermoShield HME Filter

- Pathway: 510(k) (Traditional)
- Applicant: Flexicare Medical Limited.
- Decided: Mar 22, 2017 after 120 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 K952084 (1995). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964382: Humid-Vent Filter Compact Angled (18402)/Humid-Vent Filter Compact Straight (19402), Gibeck, Inc. (1997) Summary page 4.
- K952084: Humid-Vent Filter Pedi, Gibeck, Inc. (1995) Summary page 4.

## Most influential descendants
- K241339: Besmed Bacterial Filter and HMEF (2024), 0 descendants of its own
- K210352: GGM Breathing Circuit Bacterial Filter (2022), 0 descendants of its own

## Indications for use
Flexicare’s ThermoShield HME (Heat and Moisture Exchange) Filters are intended to reduce the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient’s respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation. An HMEF is normally positioned at the patient end of the breathing system between the circuit Y-piece and the catheter mount or patient airway device. Flexicare’s ThermoShield HME Filters are single use devices for use on a single patient for up to 24hrs and are available in Adult and Mini (pediatric) sizes. Flexicare’s ThermoShield HME Filters are designed to be used in pre-hospital, hospital and homecare environments by trained personnel. Expert clinical judgment must be used in assessing patient humidification requirements.

Source page: https://510kreport.com/device/K163300
Methodology: https://510kreport.com/methodology