510(k) · Cleared
ClearedPulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nonin Medical, Inc. · DQA Oximeter
Cleared on Sep 11, 2013 as substantially equivalent to K112843 (Nonin Medical, Inc., 2012) and 1 other predicate after a 152-day review. Its family tree reaches back 8 generations to 1991. 3 later devices descend from it.
- Decided
- Sep 11, 2013
- Review
- 152 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K910772 (1991). 19 ancestors in all, the oldest K893221 (1990). 3 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 7 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 6 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 4 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 3 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 2 generations backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- 1 generation backK081285 Finger Pulse Oximeter, Model 9560Nonin Medical, Inc. · 2008
- This deviceK131021 Pulse OximeterNonin Medical, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK191403 Pulse OximeterNonin Medical, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK202743 Med-Link Temp-pulse OximeterShenzhen Med-Link Electronics Tech Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK140785 Pulse OximeterNonin Medical, Inc. · 2014
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 |
|---|---|---|---|---|---|
| −8 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −7 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −6 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −4 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −3 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −2 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| −1 | K081285 | Finger Pulse Oximeter, Model 9560 | Nonin Medical, Inc. | 2008 | — |
| 0 (this device) | K131021 | Pulse Oximeter | Nonin Medical, Inc. | 2013 | — |
| +1 | K191403 | Pulse Oximeter | Nonin Medical, Inc. | 2019 | — |
| +2 | K202743 | Med-Link Temp-pulse Oximeter | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2021 | — |
| +1 | K140785 | Pulse Oximeter | Nonin Medical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K112843 | Pulse OximeterSummary page 1…DQA Predicate Device(s): Nonin's Model 3230 finger pulse oximeter issubstantially equivalent to the Onyx Vantage 9590 cleared by the FDA under K112843 on 4/19/2012, and Model 9560 Onyx 11Finger Pulse Oximeter and cleared by the FDA un… | 2012 |
| * | K081285 | Finger Pulse Oximeter, Model 9560Summary page 1…590 cleared by the FDA under K112843 on 4/19/2012, and Model 9560 Onyx 11Finger Pulse Oximeter and cleared by the FDA under K081285 on 6/5/2008. As shown in the table below, these devices represent the same technical characteristics as th… | 2008 |
What descends from it? (3)
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 22 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K191403 (Nonin Medical, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K112843.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Model 3230 Finger Pulse oximeter Isa small, lightweight portable device Indicated for use In measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. It Isintended for spot checking of adult and pediatric patients on digits between 0.3 - 1.0 Inch (0.8 -2.5 cm) thick.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131021: 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/K131021
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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