# K021020: Terumo Gas Filter

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Cardiovascular Systems Corp.
- Decided: Jun 10, 2002 after 73 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 K832935 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832935: Gasline Filter, #EC-GLF Series, Gish Biomedical, Inc. (1983) Summary page 1.

## Indications for use
The Terumo Gas Filter is intended to remove particulate matter from the gases flowing into the cardiopulmonary bypass circuit. The Terumo Gas Filter is intended for use in procedures lasting up to 6-hours in duration.

Source page: https://510kreport.com/device/K021020
Methodology: https://510kreport.com/methodology