510(k) · Cleared
ClearedPulse Oximeter Model P10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mediana Co., Ltd. · DQA Oximeter
Cleared on Feb 9, 2011 as substantially equivalent to K963707 (Nellcor Puritan Bennett, Inc., 1996) and 2 other predicates after a 379-day review. Its family tree reaches back 3 generations to 2000. 3 later devices descend from it.
- Decided
- Feb 9, 2011
- Review
- 379 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K000126 (2000). 10 ancestors in all, the oldest K915699 (1993). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK000126 Masimo Set Radical Pulse Oximeter with Satshare, Masimo…Masimo Corp. · 2000
- 2 generations backK031330 Modification to Masimo Set Radical Pulse Oximeter with Satshare and…Masimo Corp. · 2003
- 1 generation backK033296 Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V…Masimo Corp. · 2004 · Recalled
- This deviceK100225 Pulse Oximeter Model P10Mediana Co., Ltd. · 2011
- Descendant · cites it directly · 2 of its ownK152659 V10Mediana Co., Ltd. · 2016
- Descendant · 2 generations on · 1 of its ownK170497 V10Mediana Co., Ltd. · 2017 · Recalled
- Descendant · 3 generations on · 0 of its ownK200434 V20, V20a, AVSM3 SNFMediana Co., Ltd. · 2020 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000126 | Masimo Set Radical Pulse Oximeter with Satshare, Masimo… | Masimo Corp. | 2000 | — |
| −2 | K031330 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop… | Masimo Corp. | 2003 | — |
| −1 | K033296 | Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse… | Masimo Corp. | 2004 | 1 |
| 0 (this device) | K100225 | Pulse Oximeter Model P10 | Mediana Co., Ltd. | 2011 | — |
| +1 | K152659 | V10 | Mediana Co., Ltd. | 2016 | — |
| +2 | K170497 | V10 | Mediana Co., Ltd. | 2017 | 1 |
| +3 | K200434 | V20, V20a, AVSM3 SNF | Mediana Co., Ltd. | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | K963707 | Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40)Summary page 1…or Pulse oximeter, P10 is: * rellcor Puritan Bennett (division of Tyco Healthcare Inc.) Handheld Pulse Oximeter, Model NPB-40 cleared by FDA through 510(k) No. K963707, and * Mediaid inc. Pulse Oximeter, Model 3X Series cleared by FDA through 510(k) No. K071610, and *Masimno Corp. M… | 1996 |
| * | K071610 | Mediaid Pulse Oximeter M30 and M34Summary page 1…se Oximeter, Model NPB-40 cleared by FDA through 510(k) No. K963707, and * Mediaid inc. Pulse Oximeter, Model 3X Series cleared by FDA through 510(k) No. K071610, and *Masimno Corp. Masimo SET Pulse Oximeter, Model RAD-5 cleared by FDA through 510(k) No. K033296. Device Descripti… | 2007 |
| * | K033296 | Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model…Summary page 1…r, Model 3X Series cleared by FDA through 510(k) No. K071610, and *Masimno Corp. Masimo SET Pulse Oximeter, Model RAD-5 cleared by FDA through 510(k) No. K033296. Device Description The P10 Pulse Oximter is to monitor non-invasive functional oxygen saturation of arterial hemoglobin (5p02)… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152659 | V10 | 2016 | 2 |
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 11 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K152659 (Mediana Co., Ltd., 2016) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K963707.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 P10 pulse oximeter is intended to be used to monitor functional arterial oxygen saturation (SpO 2) and pulse rate in all areas of a hospital, hospital-type facilities, intra-hospital transport and home environments. Users should be skilled at the level of a technician, doctor, nurse or medical specialist.
Note: The continuous monitoring and Spot check mode are user-selectable. The mode of operation is the continuous monitoring except when the Spot Check Mode (03) is enabled.
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/K100225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100225: Pulse Oximeter Model P10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100225
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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