# K072194: Renu Reprocessed Nellcor Oximetry Sensor, Model D-25, N-25

- Pathway: 510(k) (Traditional)
- Applicant: Renu Medical, Inc.
- Decided: Nov 29, 2007 after 114 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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) Nellcor D-25 Oximetry sensor: named in the summary without a submission number
- (no number) Nellcor N-25 Oximetry sensor: named in the summary without a submission number

## Most influential descendants
- K113727: Shenzhen Med-Link Pulse Oximeter Probe (2013), 1 descendant of its own
- K183277: SpO2 Sensor (2019), 0 descendants of its own
- K111773: Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and Neonate (2011), 0 descendants of its own

## Indications for use
D-25 continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients > 30 kg. N-25: 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/K072194
Methodology: https://510kreport.com/methodology