510(k) · Cleared
ClearedDigital Pulse Oximeter, Model 7500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nonin Medical, Inc. · DQA Oximeter
Cleared on Jul 12, 2007 as substantially equivalent to K050056 (Nonin Medical, Inc., 2005) after a 66-day review. Its family tree reaches back 2 generations to 2000. 29 later devices descend from it.
- Decided
- Jul 12, 2007
- Review
- 66 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001930 (2000). 3 ancestors in all. 29 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK001930 Model 8500, Hand Held Pulse Oximeter, Model 8500Nonin Medical, Inc. · 2000
- 1 generation backK050056 Model 2500A Palmsat Pulse OximeterNonin Medical, Inc. · 2005 · Recalled
- This deviceK071285 Digital Pulse Oximeter, Model 7500Nonin Medical, Inc. · 2007
- Descendant · cites it directly · 17 of its ownK101674 WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx · 2010
- Descendant · 2 generations on · 13 of its ownK113165 Mini-MedicAthena Gtx · 2012
- Descendant · 3 generations on · 12 of its ownK190792 BB-613WPBiobeat Technologies, Ltd. · 2019
- Descendant · cites it directly · 10 of its ownK080255 Nonin Medical, Inc., Model 7500 Digital Pulse OximeterNonin Medical, Inc. · 2008
- Descendant · 2 generations on · 7 of its ownK092101 Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc. · 2009
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K101674WVSM (Wireless Vital Signs Monitor), Model 5.0Athena Gtx · 2010 · cites it directly17descendants
- K113165Mini-MedicAthena Gtx · 2012 · 2 generations on13descendants
- K190792BB-613WPBiobeat Technologies, Ltd. · 2019 · 3 generations on12descendants
- K080255Nonin Medical, Inc., Model 7500 Digital Pulse OximeterNonin Medical, Inc. · 2008 · cites it directly10descendants
- K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc. · 2009 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001930 | Model 8500, Hand Held Pulse Oximeter, Model 8500 | Nonin Medical, Inc. | 2000 | — |
| −1 | K050056 | Model 2500A Palmsat Pulse Oximeter | Nonin Medical, Inc. | 2005 | 1 |
| 0 (this device) | K071285 | Digital Pulse Oximeter, Model 7500 | Nonin Medical, Inc. | 2007 | — |
| +1 | K101674 | WVSM (Wireless Vital Signs Monitor), Model 5.0 | Athena Gtx | 2010 | — |
| +2 | K113165 | Mini-Medic | Athena Gtx | 2012 | — |
| +3 | K190792 | BB-613WP | Biobeat Technologies, Ltd. | 2019 | — |
| +1 | K080255 | Nonin Medical, Inc., Model 7500 Digital Pulse Oximeter | Nonin Medical, Inc. | 2008 | — |
| +2 | K092101 | Reusable Pulse Oximeter Sensor, Model 8000 Series | Nonin Medical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K050056 | Model 2500A Palmsat Pulse OximeterSummary page 1…Class II, 21 CFR 870.2700 Product Code: DQA Predicate Device(s): The predicate device is the Model 2500A Digital Pulse Oximeter, K(050056 cleared on June 21, 2005. Device Description: The Nonin® Model 7500 Digital Pulse Oximeter is a portabl… | 2005 |
What descends from it? (29)
See all 292 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 7 years and passes through 1 company; a new generation was cleared every 4.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K101674 (Athena Gtx, 2010) has gone furthest, with 17 descendants of its own.
- 7 other devices also cite its predicate K050056.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Nonin® Model 7500 Digital Pulse Oximeter is a portable, tabletop device indicated for use in measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients. It is indicated for spot-checking and / or continuous monitoring of patients during both motion and non-motion conditions, and for patients who are well or poorly perfused.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071285 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071285: Digital Pulse Oximeter, Model 7500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071285
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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