510(k) · Cleared
Recalled · Class II · 2022Scan Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Withings SA · DPS Electrocardiograph
Cleared on Oct 5, 2021 as substantially equivalent to K140933 (AliveCor, Inc., 2014) after a 491-day review. Its family tree reaches back 5 generations to 1997. 6 later devices descend from it. It has been recalled once.
- Decided
- Oct 5, 2021
- Review
- 491 days
- Class
- Class II
- Product code
- DPS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K963725 (1997). 12 ancestors in all, the oldest K920984 (1992). 6 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 4 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 3 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 2 generations backK122184 Ecg CheckCardiac Designs, LLC · 2013
- 1 generation backK140933 Alivecor Heart MonitorAliveCor, Inc. · 2014 · Recalled
- This deviceK201456 Scan MonitorWithings SA · 2021
- Descendant · cites it directly · 2 of its ownK232512 Masimo W1Masimo Corporation · 2023
- Descendant · 2 generations on · 1 of its ownK240229 Masimo W1Masimo Corporation · 2024
- Descendant · cites it directly · 1 of its ownK221260 CSF-3Cardiacsense · 2023
- Descendant · cites it directly · 0 of its ownK243305 Masimo W1Masimo Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK232445 CSF-4 (CSF-4)Cardiacsense · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K232512Masimo W1Masimo Corporation · 2023 · cites it directly2descendants
- K240229Masimo W1Masimo Corporation · 2024 · 2 generations on1descendant
- K221260CSF-3Cardiacsense · 2023 · cites it directly1descendant
- K243305Masimo W1Masimo Corporation · 2025 · cites it directly0descendants
- K232445CSF-4 (CSF-4)Cardiacsense · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −4 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −3 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −2 | K122184 | Ecg Check | Cardiac Designs, LLC | 2013 | — |
| −1 | K140933 | Alivecor Heart Monitor | AliveCor, Inc. | 2014 | 1 |
| 0 (this device) | K201456 | Scan Monitor | Withings SA | 2021 | — |
| +1 | K232512 | Masimo W1 | Masimo Corporation | 2023 | — |
| +2 | K240229 | Masimo W1 | Masimo Corporation | 2024 | — |
| +1 | K221260 | CSF-3 | Cardiacsense | 2023 | — |
| +1 | K243305 | Masimo W1 | Masimo Corporation | 2025 | — |
| +2 | K232445 | CSF-4 (CSF-4) | Cardiacsense | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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 |
|---|---|---|---|
| * | K140933 | Alivecor Heart MonitorSummary page 4…uct Code: DXH; 21 C.F.R. 870.2920); Oximeter (Product Code: DQA, 21 C.F.R 870.2700) Regulatory Class: Class II Predicate Device: AliveCor, Inc. Alivecor Heart Monitor (K140933) Reference Devices: x AmZetta Technologies Private Limited B.O.L.T Pulse Oximeter (K182401) x Oxitone Medical Ltd. Oxitone… | 2014 |
| † | K182401 | B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared… | 2019 |
| † | K163382 | Oxitone 1000 | 2017 |
What descends from it? (6)
4 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 |
|---|---|---|---|---|
| Dec 19, 2022 | Class II | Z-1280-2023 | Software Design Change | A software bug eliminated the initial ECG activation and review of the ECG under a physician. However, the device is only cleared for use under the care of a physician. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K232512 (Masimo Corporation, 2023) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K140933.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
Scan Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The Scan Monitor also displays ECG rhythms and detects the presence of atrial fibrillation (when the monitor is prescribed or used under the care of a physician). The Scan Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals.
The Scan Monitor is also indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2). The Scan Monitor is intended for spot-checking of adult patients in hospitals, clinics, long-term care facilities, and homes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201456 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201456: Scan Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201456
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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