# K012715: Hygia Health Services Reprocessed Nellcot D-25 Oxisensor II

- Pathway: 510(k) (Traditional)
- Applicant: Hygia Health Services, Inc.
- Decided: Aug 1, 2003 after 717 days
- Product code: NLF (Oximeter, Reprocessed)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mallinckrodt, Inc., Nellcor Oxisensors: named in the summary without a submission number

## Most influential descendants
- K101280: Midwestern Reprocessing Center Reprocessed Pulse Oximeter Probe (2010), 0 descendants of its own

## Indications for use
The Hygia Health Services Reprocessed Nellcor Oxisensor is used as a non-invasive method to provide continuous SpO2 monitoring and pulse rate.

Source page: https://510kreport.com/device/K012715
Methodology: https://510kreport.com/methodology