510(k) · Cleared
ClearedFinger Pulse Oximeter, Model 9560
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nonin Medical, Inc. · DQA Oximeter
Cleared on Jun 5, 2008 as substantially equivalent to K053130 (Nonin Medical, Inc., 2006) and 1 other predicate after a 30-day review. Its family tree reaches back 7 generations to 1991. 40 later devices descend from it.
- Decided
- Jun 5, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K910772 (1991). 17 ancestors in all, the oldest K893221 (1990). 40 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 6 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 5 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 4 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 3 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 2 generations backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- 1 generation backK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- This deviceK081285 Finger Pulse Oximeter, Model 9560Nonin Medical, Inc. · 2008
- Descendant · cites it directly · 24 of its ownK150314 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015
- Descendant · 2 generations on · 23 of its ownK181956 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019
- Descendant · 3 generations on · 10 of its ownK181352 Loop SystemSpry Health, Inc. · 2019
- Descendant · cites it directly · 10 of its ownK092620 MD300C318 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2009
- Descendant · 2 generations on · 8 of its ownK142888 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2015
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015 · cites it directly24descendants
- K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019 · 2 generations on23descendants
- K181352Loop SystemSpry Health, Inc. · 2019 · 3 generations on10descendants
- K092620MD300C318 Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2009 · cites it directly10descendants
- K142888Fingertip Pulse OximeterBeijing Choice Electronic Technololgy Co., Ltd. · 2015 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −6 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −5 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −4 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −3 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −2 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| −1 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| 0 (this device) | K081285 | Finger Pulse Oximeter, Model 9560 | Nonin Medical, Inc. | 2008 | — |
| +1 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015 | — |
| +2 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2019 | — |
| +3 | K181352 | Loop System | Spry Health, Inc. | 2019 | — |
| +1 | K092620 | MD300C318 Fingertip Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2009 | — |
| +2 | K142888 | Fingertip Pulse Oximeter | Beijing Choice Electronic Technololgy Co., Ltd. | 2015 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 7 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 7 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K053130 | Onyx II Finger Pulse Oximeter, Model 9550Summary page 1…1 CFR 870.2700 Product Code: DQA Predicate Device(s): The predicate devices are Nonin's Onyx II® Model 9550 Finger Pulse Oximeter, K053130, cleared on January 11, 2006 and Model 4100 Patient Oximeter Module, K043359, cle… | 2006 |
| * | K043359 | 4100 Patient Oximeter ModuleSummary page 1…s Onyx II® Model 9550 Finger Pulse Oximeter, K053130, cleared on January 11, 2006 and Model 4100 Patient Oximeter Module, K043359, cleared on January 7, 2005. Device Description: The Model 9560 is a small, lightweight, portable fi… | 2005 |
What descends from it? (40)
See all 404 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 17 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 17 ancestors have a recall of any class.
- Of its descendants, K150314 (Masimo Corporation, 2015) has gone furthest, with 24 descendants of its own.
- 1 other device also cites its predicate K053130.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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® Onyx II® Model 9560 Finger Pulse Oximeter is a small, lightweight, portable, device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate of patients who are well or poorly perfused. It is intended for spot-checking of adult and pediatric patients on fingers (other than the thumb) between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick. The index finger is the recommended site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081285 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081285: Finger Pulse Oximeter, Model 9560.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081285
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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