# K904039: Reflectance Sensor (RS-10)

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor, Inc.
- Decided: Dec 27, 1990 after 114 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
549 later devices descend from it; 1 cites it directly.
2 of 550 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories) (2002), 548 descendants of its own
- K021090: Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter (2002), 426 descendants of its own
- K031740: VSM - Vital Signs Monitor, Model 53000 Series (2003), 290 descendants of its own
- K033048: Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS (2004), 272 descendants of its own
- K050844: 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL (2005), 264 descendants of its own

## Recalls of this device
- Dec 16, 2016 · Class II · Z-1125-2017: Labeling error: The label indicates the product is latex free, but the headband component included with the forehead sensor does contain latex.

Source page: https://510kreport.com/device/K904039
Methodology: https://510kreport.com/methodology