# K984033: Atlas Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Welch Allyn, Inc.
- Decided: Jul 8, 1999 after 238 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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 K911598 (1991). 3 ancestors in all.
267 later devices descend from it; 3 cite it directly.
2 of 271 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951193: Clinical Vital Signs Monitor, Model #52STP-E1, Tycos Instruments, Inc. (1996) Summary page 1.
- K970209: Capnocheck Plus, Bci Intl., Inc. (1997) Summary page 1.
- K911598: Datascope Passport Monitor, Datascope Corp. (1991) Summary page 1.

## Most influential descendants
- K022084: Atlas Monitor, Models 200,210,220 (2002), 264 descendants of its own
- 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

## 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 (SpO,) measurement ECG waveform derived from 3 or 5 Lead measurement Respiration rate/waveform derived from ECG or CO, Temperature measurement via YSI 400 series probes Non Invasive Blood Pressure (NIBP) measurement CO,, End-tidal sidestream/waveform Heart Rate derived from selected source (ECG, SpO,) 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/K984033
Methodology: https://510kreport.com/methodology