510(k) · Cleared
ClearedModel Avant 2120 Pulse Oximeter and Nibp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nonin Medical, Inc. · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Mar 22, 2004 as substantially equivalent to K013319 (Nonin Medical, Inc., 2002) and 2 other predicates after a 315-day review. Its family tree reaches back 5 generations to 1991. 42 later devices descend from it.
- Decided
- Mar 22, 2004
- Review
- 315 days
- Class
- Class II
- Product code
- DXN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K910772 (1991). 19 ancestors in all, the oldest K893221 (1990). 42 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 4 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 3 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 2 generations backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- 1 generation backK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- This deviceK031487 Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc. · 2004
- Descendant · cites it directly · 27 of its ownK040589 Modification to Avant 9600 Pulse OximeterNonin Medical, Inc. · 2004
- Descendant · cites it directly · 13 of its ownK053209 Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement…Suntech Medical, Inc. · 2006
- Descendant · 2 generations on · 9 of its ownK120465 Earlysense (Everon) SystemEarlysense, Ltd. · 2012
- Descendant · 3 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
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K040589Modification to Avant 9600 Pulse OximeterNonin Medical, Inc. · 2004 · cites it directly27descendants
- K053209Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement SystemSuntech Medical, Inc. · 2006 · cites it directly13descendants
- K120465Earlysense (Everon) SystemEarlysense, Ltd. · 2012 · 2 generations on9descendants
- K131379EarlysenseEarlysense, Ltd. · 2013 · 3 generations on7descendants
- K092101Reusable Pulse Oximeter Sensor, Model 8000 SeriesNonin Medical, Inc. · 2009 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −4 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −3 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −2 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −1 | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| 0 (this device) | K031487 | Model Avant 2120 Pulse Oximeter and Nibp | Nonin Medical, Inc. | 2004 | — |
| +1 | K040589 | Modification to Avant 9600 Pulse Oximeter | Nonin Medical, Inc. | 2004 | — |
| +1 | K053209 | Tango+ Automatic Blood Pressure and Oxygen Saturation Measurement System | Suntech Medical, Inc. | 2006 | — |
| +2 | K120465 | Earlysense (Everon) System | Earlysense, Ltd. | 2012 | — |
| +3 | K131379 | Earlysense | Earlysense, Ltd. | 2013 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 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 |
|---|---|---|---|
| * | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) MonitorSummary page 1…osmetic Act for Pulse Oximeters. (3) Legally-marketed predicate devices Model Avant MT 2120 Pulse Oximeter and NIBP, K013319, clearance date January 3, 2002., by Nonin Medical, Inc.… | 2002 |
| * | K993637 | N-395 Pulse Oximeter, with Extended Device ClaimsSummary page 2…ification a Model N-395 Pulse Oximeter with Extension of Motion Performance Claims to cover three additional oximetry sensors, K993637, clearance date November 24, 1999 made by Nellcor Puritan Bennett. Masimo SET® Radical Pulse Oximeter, K013792, clearance date D… | 1999 |
| * | K013792 | Modification to Masimo Set Radical Pulse Oximeter with Satshare and Lnop Series of…Summary page 2…rmance Claims to cover three additional oximetry sensors, K993637, clearance date November 24, 1999 made by Nellcor Puritan Bennett. Masimo SET® Radical Pulse Oximeter, K013792, clearance date December 11, 2001, made by Masimo Corporation. The NONIN® Model AvantTM 2120 Pulse Oximeter and Noninvasive Bloo… | 2001 |
What descends from it? (42)
See all 423 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 19 ancestors have a recall of any class.
- Of its descendants, K040589 (Nonin Medical, Inc., 2004) has gone furthest, with 27 descendants of its own.
- 1 other device also cites its predicate K013319.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
What is it indicated for?
The Nonin® Model Avant TM 2120 Pulse Oximeter and NIBP Monitor is a portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO 2 ), pulse rate, and blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments. The Model 2120 is intended for spot-checking and / or continuous monitoring of patients during both no motion and motion conditions, for patients who are well or poorly perfused. Its'functions may be used separately or simultaneously.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031487 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031487: Model Avant 2120 Pulse Oximeter and Nibp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031487
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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