# K992211: SPO2 Wrap Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Epic Medical Equipment Services, Inc.
- Decided: Dec 22, 1999 after 174 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
Longest line of descent: 1 generation back to K964055 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970098: E100 Series SPO2 Sensors, Epic Medical Equipment Services, Inc. (1998) Summary page 1.
- K964055: Flexi-Site (E203-01)/ Flexi-Fit (E300), Epic Medical Equipment Services, Inc. (1997) Summary page 1.

## Indications for use
The SpO2 Wrap Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg.

Source page: https://510kreport.com/device/K992211
Methodology: https://510kreport.com/methodology