# K101280: Midwestern Reprocessing Center Reprocessed Pulse Oximeter Probe

- Pathway: 510(k) (Traditional)
- Applicant: Midwest Reprocessing Center, LLC
- Decided: Oct 7, 2010 after 154 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: 16 generations back to K941811 (1994). 73 ancestors in all.
No later device cites it as a predicate yet.
0 of 74 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.
- K080424: Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and HHS-1861, Hygia Health Services, Inc. (2008) 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.
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories), Nellcor Puritan Bennett, Inc. (2002) Summary page 1.
- K863784: Nellcor N-200 (Pulse Oximeter), Nellcor, Inc. (1986) Summary page 1.
- K012715: Hygia Health Services Reprocessed Nellcot D-25 Oxisensor II, Hygia Health Services, Inc. (2003) Summary page 1.

## Indications for use
The MRC Reprocessed Pulse Oximeter sensors are used as a non-invasive method to provide continuous SP02 monitoring and pulse rate monitoring.

Source page: https://510kreport.com/device/K101280
Methodology: https://510kreport.com/methodology