510(k) · Cleared
Recalled · 2005Avant Digital Pulse Oximetry System, Models 4000, 4001
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 9, 2004 as substantially equivalent to K013319 (Nonin Medical, Inc., 2002) after a 37-day review. Its family tree reaches back 5 generations to 1991. 89 later devices descend from it. It has been recalled once.
- Decided
- Jun 9, 2004
- Review
- 37 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K910772 (1991). 12 ancestors in all, the oldest K893221 (1990). 89 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 deviceK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004
- Descendant · cites it directly · 75 of its ownK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- Descendant · 2 generations on · 40 of its ownK081285 Finger Pulse Oximeter, Model 9560Nonin Medical, Inc. · 2008
- Descendant · 3 generations on · 24 of its ownK150314 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015
- Descendant · 4 generations on · 23 of its ownK181956 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019
- Descendant · 2 generations on · 17 of its ownK082113 Nox T3, Noxturnal (PC Application)Nox Medical · 2008 · Recalled
Showing 5 of 89 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 89 · See all- K0433594100 Patient Oximeter ModuleNonin Medical, Inc. · 2005 · cites it directly75descendants
- K081285Finger Pulse Oximeter, Model 9560Nonin Medical, Inc. · 2008 · 2 generations on40descendants
- K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015 · 3 generations on24descendants
- K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019 · 4 generations on23descendants
- K082113Nox T3, Noxturnal (PC Application)Nox Medical · 2008 · 2 generations on17descendants
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) | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | — |
| +1 | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| +2 | K081285 | Finger Pulse Oximeter, Model 9560 | Nonin Medical, Inc. | 2008 | — |
| +3 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015 | — |
| +4 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2019 | — |
| +2 | K082113 | Nox T3, Noxturnal (PC Application) | Nox Medical | 2008 | 1 |
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 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 1 | 0 |
| 2022 | 9 | 0 |
| 2023 | 4 | 0 |
| 2024 | 10 | 0 |
| 2025 | 14 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013319 | Nonin Model 2120 Pulse Oximeter and Noninvasive Blood Pressure (Nibp) MonitorSummary page 1…the Avant® Model 2120 Pulse Oximeter manufactured by Nonin Medical, Inc. that was cleared by the FDA under K013319 on 1/03/02, and the Wireless Medicine LifeSync TM System (K030765). Device Description: Th… | 2002 |
| Kept off the family tree | K030765 | FDA’s K030765 is Hobbs Mistifier Spray Catheter Our reading of the summary gave K030765, FDA’s number for Hobbs Mistifier Spray Catheter (Hobbs Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Wireless Medicine LifeSync TM System”. Kept off the family tree. Summary page 1…dical, Inc. that was cleared by the FDA under K013319 on 1/03/02, and the Wireless Medicine LifeSync TM System (K030765). Device Description: The Avant Model 4000 Digital Pulse Oximetry System is a wireless pul… | 2003 |
What descends from it? (89)
See all 893 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2005 | Not classified | Z-1457-05 | Other | The product has a higher than normal locking torque, which may cause the saddle to malfunction or to break interoperatively. |
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 2.4 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K043359 (Nonin Medical, Inc., 2005) has gone furthest, with 75 descendants of its own.
- 1 other device also cites its predicate K013319.
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® Avant® Model 4000 Digital Pulse Oximetry System is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, and infant patients. It is indicated for spot-checking and / or continuous monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041156: Avant Digital Pulse Oximetry System, Models 4000, 4001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041156
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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