510(k) · Cleared
ClearedHMS-4000 Physiological Monitor, Modification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitalog Monitoring,Inc. · DQA Oximeter
Cleared on May 1, 1992 after a 198-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 102 later devices descend from it.
- Decided
- May 1, 1992
- Review
- 198 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
102 later devices descend from it, 2 citing it directly.
- This deviceK914620 HMS-4000 Physiological Monitor, ModificationVitalog Monitoring,Inc. · 1992
- Descendant · cites it directly · 100 of its ownK973920 StardustRespironics, Inc. · 1998
- Descendant · 2 generations on · 69 of its ownK000253 Silent Night VSleep Solutions, Inc. · 2000
- Descendant · 3 generations on · 63 of its ownK042745 Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 53 of its ownK083325 N-600X with SPD, Oximax N-600XCovidien · 2009
- Descendant · 5 generations on · 49 of its ownK111933 Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 102 · See all- K973920StardustRespironics, Inc. · 1998 · cites it directly100descendants
- K000253Silent Night VSleep Solutions, Inc. · 2000 · 2 generations on69descendants
- K042745Lifescreen ApneaDel Mar Reynolds Medical, Inc. · 2005 · 3 generations on63descendants
- K083325N-600X with SPD, Oximax N-600XCovidien · 2009 · 4 generations on53descendants
- K111933Covidien Nellcor Respiration Rate Software Application, Version 1.0Covidien · 2012 · 5 generations on49descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914620 | HMS-4000 Physiological Monitor, Modification | Vitalog Monitoring,Inc. | 1992 | — |
| +1 | K973920 | Stardust | Respironics, Inc. | 1998 | — |
| +2 | K000253 | Silent Night V | Sleep Solutions, Inc. | 2000 | — |
| +3 | K042745 | Lifescreen Apnea | Del Mar Reynolds Medical, Inc. | 2005 | 1 |
| +4 | K083325 | N-600X with SPD, Oximax N-600X | Covidien | 2009 | — |
| +5 | K111933 | Covidien Nellcor Respiration Rate Software Application, Version 1.0 | Covidien | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 7 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 5 | 0 |
| 2020 | 7 | 0 |
| 2021 | 2 | 0 |
| 2022 | 12 | 0 |
| 2023 | 1 | 0 |
| 2024 | 8 | 0 |
| 2025 | 12 | 0 |
| 2026 | 8 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQA? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (102)
See all 1022 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K973920 (Respironics, Inc., 1998) has gone furthest, with 100 descendants of its own.
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 | — |
https://510kreport.com/device/K914620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914620: HMS-4000 Physiological Monitor, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914620
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026