# K080424: Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and HHS-1861

- Pathway: 510(k) (Traditional)
- Applicant: Hygia Health Services, Inc.
- Decided: May 28, 2008 after 103 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
Longest line of descent: 15 generations back to K941811 (1994). 71 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041815: LNCS Oximetry Sensors, Masimo Corp. (2004) Summary page 1.
- K051212: Modification to LNCS Oximetry Sensors, Masimo Corporation (2005) Summary page 1.
- K041867: Hygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a, HHS-Max-AL, HHS-Max-N, Hygia Health Services, Inc. (2004) Summary page 1.

## 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 Masimo LNCS Pulse Oximeter sensors are used as a non-invasive method to provide continuous SPO2 monitoring and pulse rate monitoring.

Source page: https://510kreport.com/device/K080424
Methodology: https://510kreport.com/methodology