# K081536: Medisize Blue, Medisize Green, Medisize Red

- Pathway: 510(k) (Traditional)
- Applicant: Medisize BV
- Decided: Jan 23, 2009 after 235 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
1 The Medisize Red devices are breathing circuit bacterial filters, which are intended to remove microbiological and particulate matter from the gases in the breathing circuit. 2 The Medisize Blue devices are Filter/HME's. These devices are intended to remove microbiological and particulate matter from the gases in the breathing circuit and at the same time the device is intended to be positioned over a tracheotomy or endotracheal tube to warm and humidify by passive means gas breathed out by patient during spontaneous and ventilator care.

Source page: https://510kreport.com/device/K081536
Methodology: https://510kreport.com/methodology