510(k) · Cleared
ClearedSmartCardia 7L Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smartcardia SA · DSI Detector And Alarm, Arrhythmia
Cleared on Aug 30, 2023 as substantially equivalent to K192757 (Vitalconnect, Inc., 2020) and 1 other predicate after a 120-day review. Its family tree reaches back 13 generations to 1997.
- Decided
- Aug 30, 2023
- Review
- 120 days
- Class
- Class II
- Product code
- DSI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K962603 (1997). 69 ancestors in all, the oldest K843503 (1984). No later device cites it as a predicate yet.
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 9 generations between
- 3 generations backK183078 VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc. · 2019
- 2 generations backK190916 VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20Vitalconnect, Inc. · 2019
- 1 generation backK192757 VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single…Vitalconnect, Inc. · 2020
- This deviceK231276 SmartCardia 7L PlatformSmartcardia SA · 2023
Show all 13 generations
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 12 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 11 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 10 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 9 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 8 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 7 generations backK113054 EquivitalHidalgo Limited · 2012
- 6 generations backK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- 5 generations backK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
- 4 generations backK163453 VitalPatch® VitalConnect PlatformVitalconnect, Inc. · 2017
- 3 generations backK183078 VitalConnect Platform, VitalPatch BiosensorVitalconnect, Inc. · 2019
- 2 generations backK190916 VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20Vitalconnect, Inc. · 2019
- 1 generation backK192757 VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single…Vitalconnect, Inc. · 2020
- This deviceK231276 SmartCardia 7L PlatformSmartcardia SA · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −12 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −11 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −10 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −9 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −8 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −7 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
| −6 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software… | Vitalconnect, Inc. | 2014 | — |
| −5 | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | Vitalconnect, Inc. | 2015 | — |
| −4 | K163453 | VitalPatch® VitalConnect Platform | Vitalconnect, Inc. | 2017 | — |
| −3 | K183078 | VitalConnect Platform, VitalPatch Biosensor | Vitalconnect, Inc. | 2019 | — |
| −2 | K190916 | VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 | Vitalconnect, Inc. | 2019 | — |
| −1 | K192757 | VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch… | Vitalconnect, Inc. | 2020 | — |
| 0 (this device) | K231276 | SmartCardia 7L Platform | Smartcardia SA | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2016 | 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 DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192757 | VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D…Summary page 4…870.2910 Regulation: Primary Product Code: DRG Secondary Codes: DSI Primary Predicate Device: VitalConnect, Inc.; VitalConnect Biosensor; K192757 K231276 Page 1 of 6 Seco… | 2020 |
| * | K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection SystemSummary page 5…Page 1 of 6 Secondary Predicate / InfoBionics; MoMe Kardia Wireless Ambulatory ECG Monitoring and Reference Device: Detection System; K160064 Device Description: The SmartCardia 7L Platform is a body worn Holter monitoring product… | 2016 |
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 7 companies; a new generation was cleared every 1.4 years on median.
- 6 of the 69 ancestors have a recall of any class.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The SmartCardia 7L Platform is a prescribed device used for the purpose of identifying non-lethal arrhythmias. The SmartCardia 7L Platform is intended for: 1. Patients who experience transient symptoms that may suggest cardiac arrhythmia. 2. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g., atrial fibrillation). 3. Patients with symptoms that may be due to cardiac arrhythmias. These may…
Read the full statement (241 words)
The SmartCardia 7L Platform is a prescribed device used for the purpose of identifying non-lethal arrhythmias. The SmartCardia 7L Platform is intended for:
1. Patients who experience transient symptoms that may suggest cardiac arrhythmia.
2. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g., atrial fibrillation).
3. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath).
4. Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.
5. ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports. Measurements include: electrocardiogram (ECG signal), R-R interval, Heart Rate. Notification alerts can be set for one or more of these measures.
The SmartCardia 7L Platform is indicated for use on patients who are 18 years of age or older to provide monitoring of physiological information. It is intended for use in a physician office, outpatient facility, or in the patient's home.
SmartCardia 7L Platform contraindications:
1. The SmartCardia 7L Platform is contraindicated for use in a critical care setting where an immediate response to life threatening conditions such as lethal arrhythmias is required.
2. The SmartCardia 7L Platform is contraindicated for use during external defibrillation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231276 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231276: SmartCardia 7L Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231276
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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