# K241339: Besmed Bacterial Filter and HMEF

- Pathway: 510(k) (Traditional)
- Applicant: Besmed Health Business Corp
- Decided: Nov 14, 2024 after 185 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: 2 generations back to K952084 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163300: ThermoShield HME Filter, Flexicare Medical Limited. (2017) Summary page 5.

## Indications for use
Besmed HMEF Besmed HME Filter (Heat and Moisture Exchange) is intended to decrease the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient’s respiratory tract while administering anesthesia gas, providing artificial respiration, or assisting with ventilation. The Besmed HME Filter is typically placed at the patient's end of the breathing system, specifically between the circuits Y-piece and either the catheter mount or patient airway device. It is essential to note that the Besmed HME Filter is intended for single-use only and should be used on a single patient for up to 24 hours. Besmed HME Filter is intended to be used within critical care and hospital/ institutional environments by qualified personnel. Besmed Bacterial Filter The purpose of the Besmed Bacterial Filter is to diminish the passage of bacteria and viruses to patients receiving anesthesia gas. Besmed Bacterial Filter is designed for utilization in conjunction with ventilators, anesthesia machines, and open flow systems where there is a need for filtration of inhaled gases. The Besmed Bacterial Filter is a disposable device intended for the exclusive use of a single patient within a 24-hour timeframe. Bacterial Filter is designed for utilization in hospital environments by medical professionals who possess adequate training in the operation of mechanical ventilators, respiratory systems, and humidification systems.

Source page: https://510kreport.com/device/K241339
Methodology: https://510kreport.com/methodology