510(k) · Cleared
ClearedModel 3100 Wristox 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 Oct 17, 2003 as substantially equivalent to K002690 (Nonin Medical, Inc., 2000) after a 228-day review. Its family tree reaches back 1 generation to 2000. 7 later devices descend from it.
- Decided
- Oct 17, 2003
- Review
- 228 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002690 (2000). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK002690 Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500Nonin Medical, Inc. · 2000 · Recalled
- This deviceK030668 Model 3100 Wristox Pulse OximeterNonin Medical, Inc. · 2003
- Descendant · cites it directly · 5 of its ownK040178 Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceS.P.O. Medical Equipment, Ltd. · 2004
- Descendant · 2 generations on · 1 of its ownK202483 MyHomeDocMyhomedoc, Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK170181 PrizmaG-Medical Innovations, Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK223785 N9+Nonagon, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK173589 PrizmaG-Medical Innovations, Ltd. · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K040178Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch DeviceS.P.O. Medical Equipment, Ltd. · 2004 · cites it directly5descendants
- K202483MyHomeDocMyhomedoc, Ltd. · 2021 · 2 generations on1descendant
- K170181PrizmaG-Medical Innovations, Ltd. · 2017 · 2 generations on1descendant
- K223785N9+Nonagon, Ltd. · 2023 · 3 generations on0descendants
- K173589PrizmaG-Medical Innovations, Ltd. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002690 | Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500 | Nonin Medical, Inc. | 2000 | 2 |
| 0 (this device) | K030668 | Model 3100 Wristox Pulse Oximeter | Nonin Medical, Inc. | 2003 | — |
| +1 | K040178 | Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device | S.P.O. Medical Equipment, Ltd. | 2004 | — |
| +2 | K202483 | MyHomeDoc | Myhomedoc, Ltd. | 2021 | — |
| +2 | K170181 | Prizma | G-Medical Innovations, Ltd. | 2017 | — |
| +3 | K223785 | N9+ | Nonagon, Ltd. | 2023 | — |
| +2 | K173589 | Prizma | G-Medical Innovations, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K002690 | Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500Summary page 1…t 870.2700, Oximetcr Product Code: DQA Prcdicatc Device: Mode1 2500 PalrnSatO Hand Held Pulse Oximeter (K002690) Device Description: The Nonin Model 3 100 Wristox is a small, wrist worn pulse oximeter. It uses an electro-opticd sensor to no… | 2000 |
What descends from it? (7)
2 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?
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 3 100 WristOxTMPulse Oximeter is a srnalI, wrist-worn device indicated for use in measuring, displaying, and storing functional oxygen saturation of arterid hemoglobin (Sp02) and pulse rate. It may be used for spot-checking and/or data collection and recording of adult and pediatric patients in hospitals, mediczll facilities, ambulatory, subacute, and sleep study environments
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030668 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030668: Model 3100 Wristox 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/K030668
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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