# K022084: Atlas Monitor, Models 200,210,220

- Pathway: 510(k) (Special)
- Applicant: Welch Allyn, Inc.
- Decided: Sep 26, 2002 after 91 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: 4 generations back to K962603 (1997). 10 ancestors in all.
264 later devices descend from it; 2 cite it directly.
2 of 275 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984033: Atlas Monitor, Welch Allyn, Inc. (1999) Summary page 1.
- K991823: N-395 Pulse Oximeter, Model N-395, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.
- K993637: N-395 Pulse Oximeter, with Extended Device Claims, Nellcor Puritan Bennett, Inc. (1999) Summary page 1.

## Most influential descendants
- K060065: CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor (2006), 250 descendants of its own
- K072295: Capnostream 20 with A2 Adaptive Averaging Software (2007), 197 descendants of its own
- K082268: CAPNOSTREAM20 with Integrated Pulmonary Index (2009), 170 descendants of its own
- K091241: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter (2009), 155 descendants of its own
- K100428: Masimo Rainbow Set Radical 7R Pulse CO-Oximeter (2010), 115 descendants of its own

## Indications for use
The indications for use for the Atlas Monitor, model numbers 200, 210 and 220 include the monitoring of the following human physiological vital signs: Blood Oxygenation (SpO2) measurement ECG waveform derived from 3 or 5 lead measurement Respiration rate/waveform derived from ECG or CO2 Temperature measurement via YSI 400 series probes Non-Invasive Blood Pressure (NIBP) measurement CO2 End-Tidal sidestream/waveform Heart Rate derived from selected source (ECG, SpO2) The target populations are adult and pediatric populations. The monitor is intended for use within the healthcare facility setting.

Source page: https://510kreport.com/device/K022084
Methodology: https://510kreport.com/methodology