# K964055: Flexi-Site (E203-01)/ Flexi-Fit (E300)

- Pathway: 510(k) (Traditional)
- Applicant: Epic Medical Equipment Services, Inc.
- Decided: Feb 21, 1997 after 135 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K012333: Flexi-Site SP02 Ear Sensor (2001), 0 descendants of its own
- K992211: SPO2 Wrap Sensor (1999), 0 descendants of its own

Source page: https://510kreport.com/device/K964055
Methodology: https://510kreport.com/methodology