# K060382: Flo-Rite, Model 478-1; Flo-Rite II, Model 478-1; Simpulse II, Model 478-2S; Numatix, Model NCD401; Simpulse, Model 478-1

- Pathway: 510(k) (Special)
- Applicant: Ameriflo Corp.
- Decided: Apr 19, 2006 after 64 days
- Product code: NFB (Conserver, Oxygen)
- Device class: 2
- Regulation: 21 CFR 868.5905
- 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 no predicate by number.

## Indications for use
The Flo-Rite Conserving Device Regulator is intended for prescription use only, to be used in conjunction with a portable oxygen tank for supplemental oxygen therapy for in home or ambulatory application.

Source page: https://510kreport.com/device/K060382
Methodology: https://510kreport.com/methodology