# K063661: Renu Reprocessed Nellcor Oxysensor, Models D-20 and I-20

- Pathway: 510(k) (Traditional)
- Applicant: Renu Medical, Inc.
- Decided: May 25, 2007 after 168 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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-20 Oxysensor II: named in the summary without a submission number
- (no number) Nellcor I-20 Oxysensor II: named in the summary without a submission number

## Most influential descendants
- K111773: Renu Medical Reprocessed Oximax Sensors: Adult, Pediatric, Infant and Neonate (2011), 0 descendants of its own

## Indications for use
D-20 continuous non-invasive arterial oxygen saturation and pulse rate monitoring of for patients between 10 and 50 kg 1-20: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of for patients between 3 and 20 kg

Source page: https://510kreport.com/device/K063661
Methodology: https://510kreport.com/methodology