510(k) · Cleared
ClearedAtlas Monitor, Models 200,210,220
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · DQA Oximeter
Cleared on Sep 26, 2002 as substantially equivalent to K984033 (Welch Allyn, Inc., 1999) and 2 other predicates after a 91-day review. Its family tree reaches back 4 generations to 1997. 2 of the 275 devices in its family, counting itself, have a Class I recall. 264 later devices descend from it.
- Decided
- Sep 26, 2002
- Review
- 91 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K962603 (1997). 10 ancestors in all, the oldest K911598 (1991). 264 later devices descend from it, 2 citing it directly. 2 of the 275 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 3 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 2 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 1 generation backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- This deviceK022084 Atlas Monitor, Models 200,210,220Welch Allyn, Inc. · 2002
- Descendant · cites it directly · 250 of its ownK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 197 of its ownK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- Descendant · 3 generations on · 170 of its ownK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 155 of its ownK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- Descendant · 5 generations on · 115 of its ownK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
Showing 5 of 264 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 264 · See all- K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 2006 · cites it directly250descendants
- K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007 · 2 generations on197descendants
- K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · 3 generations on170descendants
- K091241Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-OximeterMasimo Corporation · 2009 · 4 generations on155descendants
- K100428Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010 · 5 generations on115descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −3 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −2 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −1 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| 0 (this device) | K022084 | Atlas Monitor, Models 200,210,220 | Welch Allyn, Inc. | 2002 | — |
| +1 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| +2 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| +3 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| +4 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| +5 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 1 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 7 | 0 |
| 2010 | 8 | 0 |
| 2011 | 6 | 0 |
| 2012 | 15 | 0 |
| 2013 | 14 | 0 |
| 2014 | 18 | 1 |
| 2015 | 13 | 0 |
| 2016 | 11 | 0 |
| 2017 | 14 | 0 |
| 2018 | 15 | 0 |
| 2019 | 16 | 0 |
| 2020 | 16 | 0 |
| 2021 | 11 | 0 |
| 2022 | 24 | 0 |
| 2023 | 16 | 0 |
| 2024 | 20 | 0 |
| 2025 | 19 | 0 |
| 2026 | 16 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K984033 | Atlas MonitorSummary page 1…ncluding cardiotachometer and rate alarm) Predicate Device: The predicate device for the Atlas Monitor is the Atlas Monitor cleared for market under 5 10(k) submission K984033, except for the improved Sp02 channel. The predicate device for the improved SpOz channel in the Atlas Monitor is the Nellcor mod… | 1999 |
| * | K991823 | N-395 Pulse Oximeter, Model N-395Summary page 1…02 channel. The predicate device for the improved SpOz channel in the Atlas Monitor is the Nellcor model N-395 pulse oximeter cleared for market under 510(k) submissions K991823 and K993637. Device Description: The Atlas Monitor is a multi-parameter device used to monitor human physiological vital signs.… | 1999 |
| * | K993637 | N-395 Pulse Oximeter, with Extended Device ClaimsSummary page 1…The predicate device for the improved SpOz channel in the Atlas Monitor is the Nellcor model N-395 pulse oximeter cleared for market under 510(k) submissions K991823 and K993637. Device Description: The Atlas Monitor is a multi-parameter device used to monitor human physiological vital signs. It combines… | 1999 |
What descends from it? (264)
See all 2642 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 5 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 2 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K060065 (Oridion Capnography, Inc., 2006) has gone furthest, with 250 descendants of its own.
- 2 other devices also cite its predicate K984033.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022084 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022084: Atlas Monitor, Models 200,210,220.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022084
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026