# K970098: E100 Series SPO2 Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Epic Medical Equipment Services, Inc.
- Decided: Apr 30, 1998 after 472 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K992211: SPO2 Wrap Sensor (1999), 0 descendants of its own
- K992092: Stat-Shell Disposable SPO2 Sensor (1999), 0 descendants of its own
- K990082: Epic SPO2 Finger Sensor, Model E403-09, E412-09 and Epic Oximeter Cable, Model E710-09 (1999), 0 descendants of its own

## Recalls of this device
- May 18, 2007 · Not classified · Z-1188-2008: Incompatible components: The Finger Clip Sensors - with a Serial Number prefix of PA514, PA515, YE508, ZC502 and ZG512 - are missing an additional diode and higher resistor in its existing configurati

## Indications for use
Reusable finger sensor for continuous non-invasive arterial oxygen saturation and pulse rate monitoring with the following oximeters: Oximeter Epic M/N Ohmeda E112-02 Novametrix 500 E192-03 Novametrix Superbright E112-03 Spacelabs oximeter module E112-04 Criticare E112-05 BCI E103-06 Datascope E112-07

Source page: https://510kreport.com/device/K970098
Methodology: https://510kreport.com/methodology