# K863784: Nellcor N-200 (Pulse Oximeter)

- Pathway: 510(k) (Traditional)
- Applicant: Nellcor, Inc.
- Decided: Nov 21, 1986 after 56 days
- Product code: DQA (Oximeter)
- 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.
273 later devices descend from it; 14 cite it directly.
3 of 274 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
- K022819: Nellcor N-200 Pulse Oximeter, Model N-200 (2002), 141 descendants of its own
- K060576: Nellcor Oximax N-600X Pulse Oximeter (2006), 140 descendants of its own
- K033298: SPO2.Com Oximetry Sensors, Multiple Models (2003), 95 descendants of its own
- K041815: LNCS Oximetry Sensors (2004), 86 descendants of its own
- K051212: Modification to LNCS Oximetry Sensors (2005), 85 descendants of its own

Source page: https://510kreport.com/device/K863784
Methodology: https://510kreport.com/methodology