# K051007: ACCU02 System

- Pathway: 510(k) (Traditional)
- Applicant: Miti Corp.
- Decided: Jun 16, 2005 after 57 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 its predicate without a number.
- (no number) Pulse Dose Series Oxygen Conserving device manufactured by DeVilbiss Health Care, Inc.: named in the summary without a submission number
- (no number) Model 8500A Pulse Oximeter, manufactured by Nonin Medical, Inc.: named in the summary without a submission number

## Indications for use
The AccuO 2 System, which provides oxygen therapy on demand, based on continuous, non-invasive monitoring of oxygen saturation, is indicated for home use by adult Chronic Obstructive Pulmonary Disease (COPD) patients who are prescribed low-flow (0-3 L/min) supplemental oxygen via nasal eannula and USP portable oxygen.

Source page: https://510kreport.com/device/K051007
Methodology: https://510kreport.com/methodology