510(k) · Cleared
ClearedMinolta Pulsox-3/Minolta Pulsox-3I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In-X Corp. · DQA Oximeter
Cleared on Aug 30, 2000 as substantially equivalent to K863918 (Marquest Medical Products, Inc., 1987) after a 616-day review. Its family tree reaches back 1 generation to 1987. 10 later devices descend from it.
- Decided
- Aug 30, 2000
- Review
- 616 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K863918 (1987). 10 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK863918 Minolta/Marquest Pulsox-7 Oxygen Saturation Monit.Marquest Medical Products, Inc. · 1987
- This deviceK984570 Minolta Pulsox-3/Minolta Pulsox-3IIn-X Corp. · 2000
- Descendant · cites it directly · 5 of its ownK040178 Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceS.P.O. Medical Equipment, Ltd. · 2004
- Descendant · cites it directly · 2 of its ownK053419 Konica Minolta Pulsox-300, 300IKonica Minolta Sensing, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK202483 MyHomeDocMyhomedoc, Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK170181 PrizmaG-Medical Innovations, Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK223785 N9+Nonagon, Ltd. · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K040178Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceS.P.O. Medical Equipment, Ltd. · 2004 · cites it directly5descendants
- K053419Konica Minolta Pulsox-300, 300IKonica Minolta Sensing, Inc. · 2006 · cites it directly2descendants
- K202483MyHomeDocMyhomedoc, Ltd. · 2021 · 2 generations on1descendant
- K170181PrizmaG-Medical Innovations, Ltd. · 2017 · 2 generations on1descendant
- K223785N9+Nonagon, Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863918 | Minolta/Marquest Pulsox-7 Oxygen Saturation Monit. | Marquest Medical Products, Inc. | 1987 | — |
| 0 (this device) | K984570 | Minolta Pulsox-3/Minolta Pulsox-3I | In-X Corp. | 2000 | — |
| +1 | K040178 | Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device | S.P.O. Medical Equipment, Ltd. | 2004 | — |
| +1 | K053419 | Konica Minolta Pulsox-300, 300I | Konica Minolta Sensing, Inc. | 2006 | — |
| +2 | K202483 | MyHomeDoc | Myhomedoc, Ltd. | 2021 | — |
| +2 | K170181 | Prizma | G-Medical Innovations, Ltd. | 2017 | — |
| +3 | K223785 | N9+ | Nonagon, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 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.
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? (1)
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 |
|---|---|---|---|
| * | K863918 | Minolta/Marquest Pulsox-7 Oxygen Saturation Monit.Summary page 1…claim made. The predicate device is the Minolta/Marquest Oxygen Saturation Monitor Pulsox-7. The predicate device is a legally marketed Class Il post-amendment device, K-863918 currently manufactured by Minolta and marketed by Marquest/Vital Signs, Englewood, Colorado. The Minolta PULSOX-3 and PULSOX-3i… | 1987 |
What descends from it? (10)
3 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?
- Its one ancestor has no recall.
- Of its descendants, K040178 (S.P.O. Medical Equipment, Ltd., 2004) 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 | — |
What is it indicated for?
The Minolta Pulsox-3 and Pulsox-3i are the devices for determination of saturation of hemoglobin (SpO.) non-invasively from light signals of two wavelengths transmitted through from tissues of patients who have pulmonary disease, pulmonary dysfunction or who need sleep study.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984570 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984570: Minolta Pulsox-3/Minolta Pulsox-3I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984570
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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