# K030271: Ventlab Bacterial Filter, Model BF100

- Pathway: 510(k) (Traditional)
- Applicant: Ventlab Corp.
- Decided: Jul 7, 2003 after 161 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
The BFIOO Disposable BacterialNiral Filter is intended for use within respiratory breathing circuits where filtration of particulate matter is desired. Each filter is intended for single patient use for up to 24 hours, and is not intended for reuse.

Source page: https://510kreport.com/device/K030271
Methodology: https://510kreport.com/methodology