# K041867: Hygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a, HHS-Max-AL, HHS-Max-N

- Pathway: 510(k) (Traditional)
- Applicant: Hygia Health Services, Inc.
- Decided: Sep 10, 2004 after 63 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: 5 generations back to K962603 (1997). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories), Nellcor Puritan Bennett, Inc. (2002)
- K863784: Nellcor N-200 (Pulse Oximeter), Nellcor, Inc. (1986) Summary page 1.

## Most influential descendants
- K080424: Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and HHS-1861 (2008), 1 descendant of its own
- K101280: Midwestern Reprocessing Center Reprocessed Pulse Oximeter Probe (2010), 0 descendants of its own

## Indications for use
The sensor is indicated for use as a non-invasive method to provide continuous SpO2 monitoring and pulse rate.

Source page: https://510kreport.com/device/K041867
Methodology: https://510kreport.com/methodology