# K990082: Epic SPO2 Finger Sensor, Model E403-09, E412-09 and Epic Oximeter Cable, Model E710-09

- Pathway: 510(k) (Traditional)
- Applicant: Epic Medical Equipment Services, Inc.
- Decided: Apr 9, 1999 after 88 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 K905140 (1991). 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.
- K905140: Satlite Plus Pulse Oximeter, Datex Division Instrumentarium Corp. (1991) Summary page 1.

## Indications for use
Reusable sensor for continuous non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg. with the Datex Satlite and AS/3 monitors.

Source page: https://510kreport.com/device/K990082
Methodology: https://510kreport.com/methodology