# K111773: Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and Neonate

- Pathway: 510(k) (Traditional)
- Applicant: Renu Medical, Inc.
- Decided: Nov 16, 2011 after 146 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: 6 generations back to K962603 (1997). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033973: Oxisensor II Recycled Sensor and Oximax Recycled Sensor, Nellcor Puritan Bennett, Inc. (2004) Summary page 1.
- K081927: Renu Medical Oximetry Sensor, Adult, Ped, Inf,Neo, Renu Medical, Inc. (2009) Summary page 1.
- K063661: Renu Reprocessed Nellcor Oxysensor, Models D-20 and I-20, Renu Medical, Inc. (2007) Summary page 1.
- K072194: Renu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25, Renu Medical, Inc. (2007) Summary page 1.

## Indications for use
OxiMax Adult: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients > 30 kg. OxiMax Pediatric: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients 10 - 50 kg. OxiMax Infant: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients between 3 kg and 20 kg. OxiMax Neonate: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients foot if < 3 kg, or finger if > 40 kg.

Source page: https://510kreport.com/device/K111773
Methodology: https://510kreport.com/methodology