# K133090: Oxicare Fingertip Pulse Oximeter

- Pathway: 510(k) (Special)
- Applicant: Delbio Incorporation
- Decided: Feb 28, 2014 after 151 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 Fingertip Pulse Oximeter (DB12) is used for spot-checking of functional arterial oxygen saturation (Sp02) and pulse rate (PR) of adult patients in hospitals, physician's office, clinical settings and home care environment. The Fingertip Pulse Oximeter (DB12) is not intended for continuous monitoring.

Source page: https://510kreport.com/device/K133090
Methodology: https://510kreport.com/methodology