# K942434: Bionaire Clear Air Air Purifier & Ionizer

- Pathway: 510(k) (Traditional)
- Applicant: Bionaire Corp.
- Decided: Dec 14, 1994 after 208 days
- Product code: FRF (Cleaner, Air, Medical Recirculating)
- Device class: 2
- Regulation: 21 CFR 880.5045
- 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. The FDA summary names its predicate without a number.
- (no number) Enviracaire EV-10: named in the summary without a submission number
- (no number) Enviracaire EV-15: named in the summary without a submission number
- (no number) Enviracaire EV-25: named in the summary without a submission number
- (no number) Hunter Fan 30100: named in the summary without a submission number
- (no number) Hunter Fan 30300: named in the summary without a submission number

## Indications for use
Bionaire Inc., is submitting a 510(k) for its family of recirculating air cleaners, (Clear Air Air Purifiers and Ionizer) primarily intended for use in home and office applications to remove airborne particulate matter in the sub-micron size range.

Source page: https://510kreport.com/device/K942434
Methodology: https://510kreport.com/methodology