# K002223: Epic SPO2 Finger Sensor, Model E412-20

- Pathway: 510(k) (Special)
- Applicant: Epic Medical Equipment Services, Inc.
- Decided: Aug 22, 2000 after 29 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.
18 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K053420: Tenacore SP02 Sensors (2006), 16 descendants of its own
- K082546: Reusable Ohmeda (U410-02), Datex (U410-09) Compatable Adult Finger Clip Sensor, Phillips Adult Soft Tip Sensor (U403S-91) (2008), 15 descendants of its own
- K142832: Unimed Disposable and Reusable SPO2 Sensors (2015), 14 descendants of its own
- K242580: Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125) (2025), 1 descendant of its own
- K202851: Spo2 Sensor (2020), 1 descendant of its own

Source page: https://510kreport.com/device/K002223
Methodology: https://510kreport.com/methodology