510(k) · Cleared
Cleared504US Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Criticare Systems, Inc. · DQA Oximeter
Cleared on May 14, 1991 after an 81-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- May 14, 1991
- Review
- 81 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK910770 504US Pulse OximeterCriticare Systems, Inc. · 1991
- Descendant · cites it directly · 5 of its ownK043463 Envitec Reusable Multi-Site Y SPO2 SensorsEnvitec-Wismar GmbH · 2005
- Descendant · 2 generations on · 4 of its ownK060675 Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH · 2006
- Descendant · 3 generations on · 3 of its ownK101690 Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with…Sentec AG · 2010 · Recalled
- Descendant · 4 generations on · 1 of its ownK151329 SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite…Sentec AG · 2015 · Recalled
- Descendant · 4 generations on · 0 of its ownK232516 Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K043463Envitec Reusable Multi-Site Y SPO2 SensorsEnvitec-Wismar GmbH · 2005 · cites it directly5descendants
- K060675Envitec Reusable Softip Y SPO2 SensorsEnvitec-Wismar GmbH · 2006 · 2 generations on4descendants
- K101690Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor Adaper CableSentec AG · 2010 · 3 generations on3descendants
- K151329SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC…Sentec AG · 2015 · 4 generations on1descendant
- K232516Sentec Digital Monitoring System (SDMS) tCOM+Sentec AG · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910770 | 504US Pulse Oximeter | Criticare Systems, Inc. | 1991 | — |
| +1 | K043463 | Envitec Reusable Multi-Site Y SPO2 Sensors | Envitec-Wismar GmbH | 2005 | — |
| +2 | K060675 | Envitec Reusable Softip Y SPO2 Sensors | Envitec-Wismar GmbH | 2006 | — |
| +3 | K101690 | Sentec Digital Monitor, V-Sign Sensor and V-Sign Sensor 2 with Digital Sensor… | Sentec AG | 2010 | 12 |
| +4 | K151329 | SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad… | Sentec AG | 2015 | 9 |
| +4 | K232516 | Sentec Digital Monitoring System (SDMS) tCOM+ | Sentec AG | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 1 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
2 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, K043463 (Envitec-Wismar GmbH, 2005) has gone furthest, with 5 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/K910770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910770: 504US Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910770
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026