# K970102: Filter

- Pathway: 510(k) (Traditional)
- Applicant: Promedic, Inc.
- Decided: Jun 24, 1997 after 162 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 K833066 (1983). 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)
- K833066: Dryden Mini Bacteria Filter, Dryden Corp. (1983) Summary page 1.
- K930760: Med-Plastics Intl., Inc. Breathing Filter, Med-Plastics Intl., Inc. (1993) Summary page 1.
- K954194: Disposable Hme/Filter, Engstrom Medical (1995) Summary page 1.

## Indications for use
To provide filtration for reducing possible contamination between patient and equipment. Environment of use: Hospital - OR, anesthesia, transport, PACU, manual resuscitators, and ICU

Source page: https://510kreport.com/device/K970102
Methodology: https://510kreport.com/methodology