# K984116: Hepa-Care Air Cleaner American Air Filter Air Filtration System Models HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C

- Pathway: 510(k) (Traditional)
- Applicant: Abatement Technologies, Inc.
- Decided: Jun 24, 1999 after 219 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K072185: Airistar Air Purification System, Model 500 & 1000 (2008), 0 descendants of its own

## Indications for use
The HEPA-CARE Air filtration systems are used for filtering out airborne particles from the air for medical purposes.

Source page: https://510kreport.com/device/K984116
Methodology: https://510kreport.com/methodology