# K210352: GGM Breathing Circuit Bacterial Filter

- Pathway: 510(k) (Traditional)
- Applicant: Great Group Medical Co, Ltd.
- Decided: Mar 27, 2022 after 412 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191909: HepaShield Bacterial Viral Breathing System Filter, Flexicare Medical Limited. (2020) Summary page 4.
- K163300: ThermoShield HME Filter, Flexicare Medical Limited. (2017) Summary page 5.

## Indications for use
GGM Breathing Circuit Bacterial Filter contains two types of bacterial filters, namely "Bacterial Filter" with only filtering function and "HME Filter" with heat and moisture exchanger function. Intended patient population: VF-2160, VF-2160-1 and VH-3110 are intended for adult patients with the tidal volume between 250ml-1500ml; VH-3210 is intended for adult patients with the tidal volume between 250ml-1000ml. Bacterial Filter (VF-2160, VF-2160-1) – The Bacterial Filter is intended to reduce the transmission of bacteria and viruses to a patient during anesthesia. For use with ventilators, anesthesia machines and open flow systems where filtration of inspired gases is desired. The Bacterial Filter is single use device for use on a single patient for up to 24hrs. The Bacterial Filter is designed to be used in hospital environments by trained personnel. HME Filter (VH-3110, VH-3210) – HME (Heat and Moisture Exchange) Filter is 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. HME Filter is normally positioned at the patient end of the breathing system between the circuits Y-piece and the catheter mount or patient airway device. HME Filter is a single use device for use on a single patient for up to 24hrs. HME Filter is designed to be used in hospital environments by trained personnel.

Source page: https://510kreport.com/device/K210352
Methodology: https://510kreport.com/methodology