510(k) · Cleared
ClearedModification to Avant 9600 Pulse 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 Jun 3, 2004 as substantially equivalent to K031487 (Nonin Medical, Inc., 2004) after an 87-day review. Its family tree reaches back 6 generations to 1991. 27 later devices descend from it.
- Decided
- Jun 3, 2004
- Review
- 87 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K910772 (1991). 20 ancestors in all, the oldest K893221 (1990). 27 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 5 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 4 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 3 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 2 generations backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- 1 generation backK031487 Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc. · 2004
- This deviceK040589 Modification to Avant 9600 Pulse OximeterNonin Medical, Inc. · 2004
- Descendant · cites it directly · 9 of its ownK120465 Earlysense (Everon) SystemEarlysense, Ltd. · 2012
- Descendant · 2 generations on · 7 of its ownK131379 EarlysenseEarlysense, Ltd. · 2013
- Descendant · cites it directly · 7 of its ownK092101 Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc. · 2009
- Descendant · cites it directly · 6 of its ownK182822 Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2019
- Descendant · 2 generations on · 6 of its ownK133661 Chair Sensing Unit for Earlysense SystemEarlysense, Ltd. · 2014
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K120465Earlysense (Everon) SystemEarlysense, Ltd. · 2012 · cites it directly9descendants
- K131379EarlysenseEarlysense, Ltd. · 2013 · 2 generations on7descendants
- K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc. · 2009 · cites it directly7descendants
- K182822Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2019 · cites it directly6descendants
- K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd. · 2014 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −5 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −4 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −3 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −2 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| −1 | K031487 | Model Avant 2120 Pulse Oximeter and Nibp | Nonin Medical, Inc. | 2004 | — |
| 0 (this device) | K040589 | Modification to Avant 9600 Pulse Oximeter | Nonin Medical, Inc. | 2004 | — |
| +1 | K120465 | Earlysense (Everon) System | Earlysense, Ltd. | 2012 | — |
| +2 | K131379 | Earlysense | Earlysense, Ltd. | 2013 | — |
| +1 | K092101 | Reusable Pulse Oximeter Sensor, Model 8000 Series | Nonin Medical, Inc. | 2009 | — |
| +1 | K182822 | Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019 | — |
| +2 | K133661 | Chair Sensing Unit for Earlysense System | Earlysense, Ltd. | 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 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K031487 | Model Avant 2120 Pulse Oximeter and Nibp Cleared while this submission was under review Summary page 1…lass II, 21 CFR 870.2700 Product Code: 74 DQA Predicate Device(s): The AvantTM 9600 is substantially equivalent to the Avant 2120 (K031487), which is also manufactured by Nonin Medical. Device Description: The AvantTM 9600 Digital Pulse O… | 2004 |
What descends from it? (27)
See all 275 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 13 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K120465 (Earlysense, Ltd., 2012) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K031487.
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 Nonin® AvantTM 9600 Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, home care, and subacute environments. It may also be used in patient transport, sleep laboratories, and EMS environments. The AvantTM 9600 is intended for continuous monitoring and / or spot-checking of patients during both no motion and motion conditions, for patients who are well or poorly perfused.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040589 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040589: Modification to Avant 9600 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/K040589
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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