510(k) · Cleared
ClearedWithings Scan Monitor 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Withings · DPS Electrocardiograph
Cleared on Aug 23, 2023 as substantially equivalent to K201456 (Withings SA, 2021) after a 152-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Aug 23, 2023
- Review
- 152 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K963725 (1997). 13 ancestors in all, the oldest K920984 (1992). No later device cites it as a predicate yet.
- Root · 6 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 5 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 4 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 3 generations backK122184 Ecg CheckCardiac Designs, LLC · 2013
- 2 generations backK140933 Alivecor Heart MonitorAliveCor, Inc. · 2014 · Recalled
- 1 generation backK201456 Scan MonitorWithings SA · 2021 · Recalled
- This deviceK230812 Withings Scan Monitor 2.0Withings · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −5 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −4 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −3 | K122184 | Ecg Check | Cardiac Designs, LLC | 2013 | — |
| −2 | K140933 | Alivecor Heart Monitor | AliveCor, Inc. | 2014 | 1 |
| −1 | K201456 | Scan Monitor | Withings SA | 2021 | 1 |
| 0 (this device) | K230812 | Withings Scan Monitor 2.0 | Withings | 2023 | — |
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 |
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 |
|---|---|---|---|
| * | K201456 | Scan MonitorSummary page 4…Cardiovascular 3. Predicate device Information Predicate Manufacturer: Withings Predicate device name: Scan Monitor Predicate 510(k) number: K201456 4. Description of the device The Withings Scan Monitor 2.0 is a connected smart scale with a retractable handle, with Bluetooth… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 6 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 13 ancestors have a recall of any class.
- 3 other devices also cite its predicate K201456.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
The Withings Scan Monitor 2.0 is intended to record, store and transfer lead II and lead-III of a two-channel electrocardiogram (ECG). In addition, it calculates and displays leads I, aVR, aVF, aVL.
The Withings Scan Monitor 2.0 also displays ECG rhythms and detects the presence of atrial fibrillation (when the monitor is prescribed or used under care of a physician).
The Withings Scan Monitor 2.0 is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals.
The Withings Scan Monitor 2.0 is intended for adult patients in hospitals, clinics, long-term care facilities, and homes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230812: Withings Scan Monitor 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230812
Report an extraction error
Are you the manufacturer?
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