510(k) · Cleared
Recalled · 2003Minolta Pulsox-3SI, Pulsox-3IA, Pulsox-3LI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Konica Minolta Sensing, Inc. · DQA Oximeter
Cleared on Aug 2, 2001 after a 171-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 2, 2001
- Review
- 171 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 2
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK010413 Minolta Pulsox-3SI, Pulsox-3IA, Pulsox-3LIKonica Minolta Sensing, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK053419 Konica Minolta Pulsox-300, 300IKonica Minolta Sensing, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK033711 Fukuda Denshi Dynascope Model DS-5000 Central Telemetry SystemFukuda Denshi USA, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK113865 PultolSharp Corporation · 2012
- Descendant · 2 generations on · 0 of its ownK103134 Fukuda DenshiFukuda Denshi USA, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK090438 Reusable Envitec Finger SPO2 Sensor-HP/Philips Compatible, Models…Envitec-Wismar GmbH · 2009
Most influential descendants
Showing 5 of 5 · See all- K053419Konica Minolta Pulsox-300, 300IKonica Minolta Sensing, Inc. · 2006 · cites it directly2descendants
- K033711Fukuda Denshi Dynascope Model DS-5000 Central Telemetry SystemFukuda Denshi USA, Inc. · 2004 · cites it directly1descendant
- K113865PultolSharp Corporation · 2012 · 2 generations on0descendants
- K103134Fukuda DenshiFukuda Denshi USA, Inc. · 2011 · 2 generations on0descendants
- K090438Reusable Envitec Finger SPO2 Sensor-HP/Philips Compatible, Models F-2412, F-2414-15…Envitec-Wismar GmbH · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010413 | Minolta Pulsox-3SI, Pulsox-3IA, Pulsox-3LI | Konica Minolta Sensing, Inc. | 2001 | — |
| +1 | K053419 | Konica Minolta Pulsox-300, 300I | Konica Minolta Sensing, Inc. | 2006 | — |
| +1 | K033711 | Fukuda Denshi Dynascope Model DS-5000 Central Telemetry System | Fukuda Denshi USA, Inc. | 2004 | — |
| +2 | K113865 | Pultol | Sharp Corporation | 2012 | — |
| +2 | K103134 | Fukuda Denshi | Fukuda Denshi USA, Inc. | 2011 | — |
| +2 | K090438 | Reusable Envitec Finger SPO2 Sensor-HP/Philips Compatible, Models F-2412… | Envitec-Wismar GmbH | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 14, 2003 | Not classified | Z-0290-04 | Other | Error in the internal software. When a pulse level is high or subject has SPO2 of less than 80%, the data shifts. |
| Nov 14, 2003 | Not classified | Z-0289-04 | Other | Error in the internal software. When a pulse level is high or subject has SPO2 of less than 80%, the data shifts. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053419 (Konica Minolta Sensing, Inc., 2006) has gone furthest, with 2 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/K010413 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010413: Minolta Pulsox-3SI, Pulsox-3IA, Pulsox-3LI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010413
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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