510(k) · Cleared
ClearedKonica Minolta Pulsox-300, 300I
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 May 11, 2006 as substantially equivalent to K984570 (In-X Corp., 2000) and 1 other predicate after a 154-day review. Its family tree reaches back 2 generations to 1987. 2 later devices descend from it.
- Decided
- May 11, 2006
- Review
- 154 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K863918 (1987). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK863918 Minolta/Marquest Pulsox-7 Oxygen Saturation Monit.Marquest Medical Products, Inc. · 1987
- 1 generation backK984570 Minolta Pulsox-3/Minolta Pulsox-3IIn-X Corp. · 2000
- This deviceK053419 Konica Minolta Pulsox-300, 300IKonica Minolta Sensing, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK113865 PultolSharp Corporation · 2012
- Descendant · cites it directly · 0 of its ownK090438 Reusable Envitec Finger SPO2 Sensor-HP/Philips Compatible, Models…Envitec-Wismar GmbH · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K863918 | Minolta/Marquest Pulsox-7 Oxygen Saturation Monit. | Marquest Medical Products, Inc. | 1987 | — |
| −1 | K984570 | Minolta Pulsox-3/Minolta Pulsox-3I | In-X Corp. | 2000 | — |
| 0 (this device) | K053419 | Konica Minolta Pulsox-300, 300I | Konica Minolta Sensing, Inc. | 2006 | — |
| +1 | K113865 | Pultol | Sharp Corporation | 2012 | — |
| +1 | K090438 | Reusable Envitec Finger SPO2 Sensor-HP/Philips Compatible, Models F-2412… | Envitec-Wismar GmbH | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 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? (2)
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 |
|---|---|---|---|
| * | K984570 | Minolta Pulsox-3/Minolta Pulsox-3ISummary page 1…de. The predicate devices are the Minolta Oxygen Saturation Monitor PULSOX-3 and PULSOX-3Si. The predicate devices are legally marketed Class II post-amrendment devices, K984570 and K010413 currently manufactured by Konica Minolta Sensing, Inc., Aichi, Japan. The Konica Minolta Models PULSOX-300 and PULSOX… | 2000 |
| * | K010413 | Minolta Pulsox-3SI, Pulsox-3IA, Pulsox-3LISummary page 1…icate devices are the Minolta Oxygen Saturation Monitor PULSOX-3 and PULSOX-3Si. The predicate devices are legally marketed Class II post-amrendment devices, K984570 and K010413 currently manufactured by Konica Minolta Sensing, Inc., Aichi, Japan. The Konica Minolta Models PULSOX-300 and PULSOX-300i are de… | 2001 |
What descends from it? (2)
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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 13.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K113865 (Sharp Corporation, 2012) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K984570.
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 Konica Minolta Models PULSOX-300 and PULSOX-300i are devices designed for
non-invasive measurement of the oxygen saturation of arterial hemoglobin (SpO 2 ) and
pulse rate from light signals of two wavelengths transmitted through tissues of adult
patients who have pulmonary disease, pulmonary dysfunction, or who need sleep study.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053419: Konica Minolta Pulsox-300, 300I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053419
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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