510(k) · Cleared
ClearedNonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nonin Medical, Inc. · DQA Oximeter
Cleared on Jan 3, 2002 as substantially equivalent to K970763 (Medical Data Electronics, 1997) and 2 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1991. 124 later devices descend from it.
- Decided
- Jan 3, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K910772 (1991). 11 ancestors in all, the oldest K893221 (1990). 124 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK910772 Propaq 102, 104 and 106Protocol Systems, Inc. · 1991
- 3 generations backK972020 Oscillomate Non-Invasive Blood Pressure MonitorCas Medical Systems, Inc. · 1998
- 2 generations backK980879 Oscillomate Nibp / SP02 Ems MonitorCas Medical Systems, Inc. · 1998
- 1 generation backK982776 9303 Neonatal/Adult Vital Signs MonitorCas Medical Systems, Inc. · 1998
- This deviceK013319 Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure…Nonin Medical, Inc. · 2002
- Descendant · cites it directly · 89 of its ownK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 75 of its ownK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- Descendant · cites it directly · 42 of its ownK031487 Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc. · 2004
- Descendant · 3 generations on · 40 of its ownK081285 Finger Pulse Oximeter, Model 9560Nonin Medical, Inc. · 2008
- Descendant · 2 generations on · 27 of its ownK040589 Modification to Avant 9600 Pulse OximeterNonin Medical, Inc. · 2004
Showing 5 of 124 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 124 · See all- K041156Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · cites it directly89descendants
- K0433594100 Patient Oximeter ModuleNonin Medical, Inc. · 2005 · 2 generations on75descendants
- K031487Model Avant 2120 Pulse Oximeter and NibpNonin Medical, Inc. · 2004 · cites it directly42descendants
- K081285Finger Pulse Oximeter, Model 9560Nonin Medical, Inc. · 2008 · 3 generations on40descendants
- K040589Modification to Avant 9600 Pulse OximeterNonin Medical, Inc. · 2004 · 2 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910772 | Propaq 102, 104 and 106 | Protocol Systems, Inc. | 1991 | — |
| −3 | K972020 | Oscillomate Non-Invasive Blood Pressure Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −2 | K980879 | Oscillomate Nibp / SP02 Ems Monitor | Cas Medical Systems, Inc. | 1998 | — |
| −1 | K982776 | 9303 Neonatal/Adult Vital Signs Monitor | Cas Medical Systems, Inc. | 1998 | — |
| 0 (this device) | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor | Nonin Medical, Inc. | 2002 | — |
| +1 | 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 | K031487 | Model Avant 2120 Pulse Oximeter and Nibp | Nonin Medical, Inc. | 2004 | — |
| +3 | K081285 | Finger Pulse Oximeter, Model 9560 | Nonin Medical, Inc. | 2008 | — |
| +2 | K040589 | Modification to Avant 9600 Pulse Oximeter | Nonin Medical, Inc. | 2004 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 7 | 0 |
| 2013 | 6 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 7 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 10 | 0 |
| 2020 | 8 | 0 |
| 2021 | 2 | 0 |
| 2022 | 11 | 0 |
| 2023 | 6 | 0 |
| 2024 | 10 | 0 |
| 2025 | 15 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K970763 | Modular Telemetry System (MTS) Option for the Mde Escort II MonitorSummary page 1…een established under Section 514 of the Food, Drug and Cosmetic Act for Pulse Oximeters. (3) Legally-marketed predicate devices MTS Option for the ESCORT® O Monitor, K970763, made by Medical Data Electronics, clearance date, July 14, 1997. Model 9303 Neonatal / Adult Vital Signs Monitor, K 982776, mad… | 1997 |
| * | K982776 | 9303 Neonatal/Adult Vital Signs MonitorSummary page 1…evices MTS Option for the ESCORT® O Monitor, K970763, made by Medical Data Electronics, clearance date, July 14, 1997. Model 9303 Neonatal / Adult Vital Signs Monitor, K 982776, made by CAS Medical Systems, Inc., clearance date, November 2, 1998. OSCAR 2, K003004, made by SunTech Medical Instruments, cle… | 1998 |
| * | K003004 | Oscar 2, Model 222Summary page 1…clearance date, July 14, 1997. Model 9303 Neonatal / Adult Vital Signs Monitor, K 982776, made by CAS Medical Systems, Inc., clearance date, November 2, 1998. OSCAR 2, K003004, made by SunTech Medical Instruments, clearance date, October 25, 2000. The NONIN® Model 2120 Pulse Oximeter and Noninvasive Blo… | 2000 |
What descends from it? (124)
See all 1242 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 11 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K041156 (Nonin Medical, Inc., 2004) has gone furthest, with 89 descendants of its own.
- 3 other devices also cite its predicate K970763.
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® Model 2120 Pulse Oximeter and NIBP Monitor is a portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (Sp0,), 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. Its functions may be used separately or simultaneously. The…
Read the full statement (166 words)
The NONIN® Model 2120 Pulse Oximeter and NIBP Monitor is a portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (Sp0,), 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. Its functions may be used separately or simultaneously.
The pulse oximeter is intended for noninvasively monitoring the oxygen saturation and pulse rate of adult, pediatric, infant, and neonatal patients in hospitals, medical facilities, and subacute environments. It may be used for spot-checking and/or continuous monitoring of patients.
The blood pressure monitor is intended for noninvasively monitoring the blood pressure of adult and pediatric patients in hospitals, medical facilities, and subacute environments. The blood pressure monitor is not intended for use with neonates. It is intended for attended care and may be used for spot-checking. The Model 2120 should be used for patients with arm circumferences of 18-42 cm.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013319: Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013319
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026