# K122927: Oxicare Fingertip Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Delbio Incorporated
- Decided: Dec 20, 2012 after 87 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The OxiCare Fingertip Pulse Oximeter, model DB11 is indicated for spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR) of adult and pediatric patients in hospitals, physician's office, clinical settings and home care environment. The OxiCare Fingertip Pulse Oximeter, model 0811 is not intended for continuous monitoring.

Source page: https://510kreport.com/device/K122927
Methodology: https://510kreport.com/methodology