# K022819: Nellcor N-200 Pulse Oximeter, Model N-200

- Pathway: 510(k) (Special)
- Applicant: Nellcor Puritan Bennett, Inc.
- Decided: Sep 24, 2002 after 29 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
Longest line of descent: 1 generation back to K863784 (1986). 1 ancestor in all.
141 later devices descend from it; 1 cites it directly.
0 of 143 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863784: Nellcor N-200 (Pulse Oximeter), Nellcor, Inc. (1986) Summary page 1.

## Most influential descendants
- K060576: Nellcor Oximax N-600X Pulse Oximeter (2006), 140 descendants of its own
- K090360: Philips M3001A Multi Measurement Server (2009), 84 descendants of its own
- K083325: N-600X with SPD, Oximax N-600X (2009), 53 descendants of its own
- K111933: Covidien Nellcor Respiration Rate Software Application, Version 1.0 (2012), 49 descendants of its own
- K120366: Intellivue Patient Monitor (2012), 46 descendants of its own

## Indications for use
The Nellcor N-200 pulse oximeter is intended for non-invasive, continuous, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate, and pulse amplitude. This device is for prescription use only.

Source page: https://510kreport.com/device/K022819
Methodology: https://510kreport.com/methodology