510(k) · Cleared
Cleared4100 Patient Oximeter Module
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 7, 2005 as substantially equivalent to K041156 (Nonin Medical, Inc., 2004) after a 32-day review. Its family tree reaches back 6 generations to 1991. 75 later devices descend from it.
- Decided
- Jan 7, 2005
- Review
- 32 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K910772 (1991). 13 ancestors in all, the oldest K893221 (1990). 75 later devices descend from it, 4 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 backK041156 Avant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. · 2004 · Recalled
- This deviceK043359 4100 Patient Oximeter ModuleNonin Medical, Inc. · 2005
- Descendant · cites it directly · 40 of its ownK081285 Finger Pulse Oximeter, Model 9560Nonin Medical, Inc. · 2008
- Descendant · 2 generations on · 24 of its ownK150314 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015
- Descendant · 3 generations on · 23 of its ownK181956 Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019
- Descendant · cites it directly · 17 of its ownK082113 Nox T3, Noxturnal (PC Application)Nox Medical · 2008 · Recalled
- Descendant · cites it directly · 14 of its ownK083309 Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · See all- K081285Finger Pulse Oximeter, Model 9560Nonin Medical, Inc. · 2008 · cites it directly40descendants
- K150314Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2015 · 2 generations on24descendants
- K181956Masimo MightySat Rx Fingertip Pulse OximeterMasimo Corporation · 2019 · 3 generations on23descendants
- K082113Nox T3, Noxturnal (PC Application)Nox Medical · 2008 · cites it directly17descendants
- K083309Zargis Acoustic Cardioscan, Version 9.33Zargis Medical Corp. · 2009 · cites it directly14descendants
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 | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001 | Nonin Medical, Inc. | 2004 | 1 |
| 0 (this device) | K043359 | 4100 Patient Oximeter Module | Nonin Medical, Inc. | 2005 | — |
| +1 | K081285 | Finger Pulse Oximeter, Model 9560 | Nonin Medical, Inc. | 2008 | — |
| +2 | K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2015 | — |
| +3 | K181956 | Masimo MightySat Rx Fingertip Pulse Oximeter | Masimo Corporation | 2019 | — |
| +1 | K082113 | Nox T3, Noxturnal (PC Application) | Nox Medical | 2008 | 1 |
| +1 | K083309 | Zargis Acoustic Cardioscan, Version 9.33 | Zargis Medical Corp. | 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 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 9 | 0 |
| 2023 | 4 | 0 |
| 2024 | 8 | 0 |
| 2025 | 12 | 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? (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 |
|---|---|---|---|
| * | K041156 | Avant Digital Pulse Oximetry System, Models 4000, 4001Summary page 1…e Avant® Model 4000 Pulse Oximetry System manufactured by Nonin Medical, Inc. that was cleared by the FDA under K041156 on 6/09/04. Device Description: Nonin's Model 4100 Bluetooth® - enabled wrist-worn Patient… | 2004 |
What descends from it? (75)
See all 754 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 14 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K081285 (Nonin Medical, Inc., 2008) has gone furthest, with 40 descendants of its own.
- 2 other devices also cite its predicate K041156.
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 Bluetooth® - enabled Model 4100 Patient Oximeter Module is indicated for
use in measuring and transmitting functional oxygen saturation of arterial hemoglobin
(SpO2), pulse rate, and plethysmographic data to a compatible Bluetooth,- enabled
device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043359 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043359: 4100 Patient Oximeter Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043359
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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