510(k) Report

510(k) · Cleared

Cleared

ScioCardio ECG Transmitter

K171019510(k) TraditionalCleared May 30, 2018420-day reviewClass II21 CFR 870.2910

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Synergen Technology Labs, LLC · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

Cleared on May 30, 2018 as substantially equivalent to K150289 (Cardioline S.P.A, 2015) and 1 other predicate after a 420-day review. Its family tree reaches back 6 generations to 1988.

Decided
May 30, 2018
Review
420 days
Class
Class II
Product code
DRG
Recalls
None
Predicates
2

Its longest line of descent runs back 6 generations to K882803 (1988). 20 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2015: 1 other ancestor2009: 1 other ancestor2008: 1 other ancestor2005: 2 other ancestors1998: 1 other ancestor2004: 1 other ancestor2002: 1 other ancestor1993: 1 other ancestor1989: 1 other ancestor2001: 1 other ancestor2000: 2 other ancestors1996: 1 other ancestorReference device: K142349 · TM eCloud ECG Analysis System · Telemed Solutions, Inc. · 2015K882803 · ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST · Advanced Cardiovascular Systems, Inc. · 1988K012241 · Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 · Cardionet, Inc. · 2002K052240 · Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 · Cardionet, Inc. · 2005K063222 · Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 · Cardionet, Inc. · 2006K072558 · Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 · Cardionet, Inc. · 2007K112921 · Medicalgorithmics Unified Arrhythmia Diagnostic System · Medicalgorithmics S.A. · 201219851990199520002005201020152020
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 4 other ancestors3 generations back: 5 other ancestors4 generations back: 4 other ancestors K112921 · Medicalgorithmics Unified Arrhythmia Diagnostic System · Medicalgorithmics S.A. · 2012K072558 · Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 · Cardionet, Inc. · 2007K063222 · Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 · Cardionet, Inc. · 2006K052240 · Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 · Cardionet, Inc. · 2005K012241 · Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 · Cardionet, Inc. · 2002K882803 · ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST · Advanced Cardiovascular Systems, Inc. · 1988−50
  1. Root · 6 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
  2. 5 generations backK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
  3. 4 generations backK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
  4. 3 generations backK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
  5. 2 generations backK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
  6. 1 generation backK112921 Medicalgorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A. · 2012
  7. This deviceK171019 ScioCardio ECG TransmitterSynergen Technology Labs, LLC · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K882803ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc.1988—
−5K012241Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001Cardionet, Inc.2002—
−4K052240Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc.2005—
−3K063222Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004Cardionet, Inc.2006—
−2K072558Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005Cardionet, Inc.2007—
−1K112921Medicalgorithmics Unified Arrhythmia Diagnostic SystemMedicalgorithmics S.A.2012—
0 (this device)K171019ScioCardio ECG TransmitterSynergen Technology Labs, LLC2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199310
199610
199810
200020
200110
200210
200410
200520
200810
200910
201510
FIG. 1 — Lineage of K171019, 1988–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DRG? 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 DRG device

  1. #1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K150289Cardioline HD+
Summary page 4
…gulatory Class: II Product Code: DRG Legally Marketed Predicate Devices Information: Trade/Device Name: Cardioline HD+ made by Cardioline S.p.A. Premarket Notification K150289 Regulation Number: 870.2910 Regulation Name: Transmitters and Receivers, Physiological Signal, Radiofrequency Regulatory Class: I…
Cardioline S.P.A2015—
*K112921Medicalgorithmics Unified Arrhythmia Diagnostic System
Summary page 4
…eivers, Physiological Signal, Radiofrequency Regulatory Class: II Product Code: DRG Trade/Device Name: PocketECG v2 made by Medicalgorithmics LLC Premarket Notification K112921 Regulation Number: 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: II Product Code: DSI…
Medicalgorithmics S.A.2012—
†K142349TM eCloud ECG Analysis SystemTelemed Solutions, Inc.2015—

Also cleared against K150289: 2 other devices →

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 30 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
  • 1 of the 20 ancestors has a recall of any class.
  • 2 other devices also cite its predicate K150289.

How does its category compare?

All DRG devices

DRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · DRG

3in 2025

2007: 62008: 52009: 132010: 102011: 92012: 122013: 132014: 102015: 22016: 22017: 72018: 62019: 52020: 62021: 22022: 62023: 42024: 32025: 32026 (partial year): 2
2007high 13 (2009) · low 2 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRG

127in 2025

2007: 63 days median2008: 74 days median2009: 94 days median2010: 68 days median2011: 104 days median2012: 103 days median2013: 146 days median2014: 177 days median2017: 98 days median2018: 220 days median2019: 122 days median2020: 159 days median2022: 287 days median2023: 212 days median2024: 125 days median2025: 127 days median
2007high 287 (2022) · low 63 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRG

3in 2007

2007: 32026 (partial year): 1
2007high 3 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRG

52in 2025

2007: 142008: 92009: 52010: 132011: 122012: 92013: 132014: 972015: 1312016: 1822017: 4842018: 1662019: 702020: 822021: 1072022: 432023: 192024: 262025: 52
2007high 484 (2017) · low 5 (2009)2025

MAUDE reports naming product code DRG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007663314
200857409
2009139405
20101068013
20119104012
20121210309
201313146013
201410177097
20152—0131
20162—0182
20177980484
201862200166
20195122070
20206159082
20212—0107
20226287043
20234212019
20243125026
20253127052
20262—1—

What is it indicated for?

ScioCardio ECG transmitter is a physiological ECG acquisition module. It records and transmits the data acquired, to a compatible mobile phone via Bluetooth low energy link, for visualization without making any analysis or filtering to the data acquired. ScioCardio ECG transmitter acquires Lead II and Lead III ECG signals meeting the AAMI/ANSI/IEC standards for ambulatory ECG acquisition, via three electrodes attached to the patient's body. ScioCardio…

Read the full statement (180 words)

ScioCardio ECG transmitter is a physiological ECG acquisition module. It records and transmits the data acquired, to a compatible mobile phone via Bluetooth low energy link, for visualization without making any analysis or filtering to the data acquired.

ScioCardio ECG transmitter acquires Lead II and Lead III ECG signals meeting the AAMI/ANSI/IEC standards for ambulatory ECG acquisition, via three electrodes attached to the patient's body.

ScioCardio ECG transmitter is a battery powered wearable device which allows the patient to be free to moving while wearing the device.

ScioCardio ECG transmitter transmits the acquired physiological signals in real-time to a compatible mobile phone where ScioCardio Mobile App is installed. ECG data is stored in the mobile phone verbatim without any sampling adjustment or any other modifications and also is displayed in the Mobile App.

ScioCardio ECG transmitter is a prescription only device which is intended for use under the supervision of a physician or those knowledgeable in all aspects of ECG morphology, rhythm and arrhythmia.

ScioCardio ECG transmitter and ScioCardio Mobile App are intended to be used on adult patients only.

Indications for use as stated in the FDA summary.

Also cleared against K150289

2 other devices cite the same predicate.

  • K223670MESI mTablet ECG Diagnostic System, MESI mTablet ECGMesi, Development of Medical Devices, Ltd.; Mesi D.O.O. · 2023
  • K220526HD+12, HD+15Cardioline S.P.A · 20231 recall

More from Synergen Technology Labs, LLC

2 FDA decisions under this applicant name. See the company

  • K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC · 2026

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The DRG category page

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https://510kreport.com/device/K171019 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171019: ScioCardio ECG Transmitter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171019

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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