510(k) Report

510(k) · Cleared

Cleared

Heartcheck Ecg Pen with Gems Home

K121009510(k) TraditionalCleared May 17, 201244-day reviewClass II21 CFR 870.2340

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

Cardiocomm Solutions, Inc. · DPS Electrocardiograph

Cleared on May 17, 2012 as substantially equivalent to K093872 (Beijing Choice Electronic Technololgy Co., Ltd., 2010) and 1 other predicate after a 44-day review. Its family tree reaches back 5 generations to 1997.

Decided
May 17, 2012
Review
44 days
Class
Class II
Product code
DPS
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K963725 (1997). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2010: 1 other ancestor2006: 1 other ancestor1999: 1 other ancestorK963725 · Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) · Card Guard, Ltd. · 1997K012012 · Ecg Home · H&C Medical Devices Spa · 2002K042814 · Readmyheart · Dailycare Biomedical, Inc. · 2005K052303 · Readmyheart, Model RMH2.0 · Dailycare Biomedical, Inc. · 2005K111159 · Heartcheck Pen Handheld Ecg with Gems Home · Cardiocomm Solutions, Inc. · 20111995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 1 other ancestor K111159 · Heartcheck Pen Handheld Ecg with Gems Home · Cardiocomm Solutions, Inc. · 2011K052303 · Readmyheart, Model RMH2.0 · Dailycare Biomedical, Inc. · 2005K042814 · Readmyheart · Dailycare Biomedical, Inc. · 2005K012012 · Ecg Home · H&C Medical Devices Spa · 2002K963725 · Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) · Card Guard, Ltd. · 1997−50
  1. Root · 5 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
  2. 4 generations backK012012 Ecg HomeH&C Medical Devices Spa · 2002
  3. 3 generations backK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
  4. 2 generations backK052303 Readmyheart, Model RMH2.0Dailycare Biomedical, Inc. · 2005
  5. 1 generation backK111159 Heartcheck Pen Handheld Ecg with Gems HomeCardiocomm Solutions, Inc. · 2011
  6. This deviceK121009 Heartcheck Ecg Pen with Gems HomeCardiocomm Solutions, Inc. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K963725Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified)Card Guard, Ltd.1997—
−4K012012Ecg HomeH&C Medical Devices Spa2002—
−3K042814ReadmyheartDailycare Biomedical, Inc.2005—
−2K052303Readmyheart, Model RMH2.0Dailycare Biomedical, Inc.2005—
−1K111159Heartcheck Pen Handheld Ecg with Gems HomeCardiocomm Solutions, Inc.2011—
0 (this device)K121009Heartcheck Ecg Pen with Gems HomeCardiocomm Solutions, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200610
201010
FIG. 1 — Lineage of K121009, 1997–2012Source: 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 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. #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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
*K093872Handheld Ecg Monitor, Model MD100
Summary page 2
…has low battery voltage indication function. 2 AAA batteries supply the power for the monitor. Predicate Device(s): Handheld ECG Monitor MD 100 (K093872) HeartCheck Pen Handheld ECG with GEMS Home (Ki 1…
Beijing Choice Electronic Technololgy Co., Ltd.2010—
*K111159Heartcheck Pen Handheld Ecg with Gems HomeCardiocomm Solutions, Inc.2011—

Also cleared against K093872: 3 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 15 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
  • None of the 8 ancestors has a recall.
  • 3 other devices also cite its predicate K093872.

How does its category compare?

All DPS devices

DPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · DPS

6in 2025

2007: 112008: 132009: 142010: 112011: 222012: 122013: 102014: 112015: 82016: 112017: 92018: 142019: 32020: 62021: 52022: 62023: 102024: 82025: 62026 (partial year): 6
2007high 22 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DPS

163in 2025

2007: 87 days median2008: 31 days median2009: 84 days median2010: 104 days median2011: 154 days median2012: 117 days median2013: 134 days median2014: 253 days median2015: 178 days median2016: 229 days median2017: 177 days median2018: 221 days median2019: 178 days median2020: 224 days median2021: 135 days median2022: 244 days median2023: 236 days median2024: 260 days median2025: 163 days median2026 (partial year): 258 days median
2007high 260 (2024) · low 31 (2008)2026

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

Recalls per year · DPS

3in 2025

2007: 22009: 12010: 22011: 12019: 92020: 22021: 12022: 12023: 32024: 4, 1 Class I2025: 32026 (partial year): 4
2007high 9 (2019) · low 0 (2008)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DPS

55in 2025

2007: 92008: 172009: 142010: 212011: 1212012: 562013: 152014: 152015: 302016: 122017: 152018: 192019: 272020: 592021: 242022: 592023: 542024: 642025: 55
2007high 121 (2011) · low 9 (2007)2025

MAUDE reports naming product code DPS, 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
2007118729
20081331017
20091484114
201011104221
2011221541121
201212117056
201310134015
201411253015
20158178030
201611229012
20179177015
201814221019
20193178927
20206224259
20215135124
20226244159
202310236354
202482604 (1)64
20256163355
202662584—

What is it indicated for?

The HeartCheck ECU Pen with GEMS Home is a teleniedicine based solution that is intended to enable adult patients to record, store, transfer and display single channel ECG waveforms while involved in everyday activities anywhere. The HeartCheck ECG Pen combined with GEMS Home enables the person to send their EGG recordings to a medical service for review and interpretation by a qualified health service professional such as a physician. GEMS Home use is…

Read the full statement (125 words)

The HeartCheck ECU Pen with GEMS Home is a teleniedicine based solution that is intended to enable adult patients to record, store, transfer and display single channel ECG waveforms while involved in everyday activities anywhere. The HeartCheck ECG Pen combined with GEMS Home enables the person to send their EGG recordings to a medical service for review and interpretation by a qualified health service professional such as a physician. GEMS Home use is not intended to substitute for a hospital. diagnostic ECU test. The software and hardware are not intended for recording and transmission of user's EGG signal simultaneously. Patients with implanted pacemaker or defibrillator are not recommended to use this device. GEMS Home is a simple software user interface with ECU trace viewing function.

Indications for use as stated in the FDA summary.

Also cleared against K093872

3 other devices cite the same predicate.

  • K170954Portable ECG MonitorContec Medical Systems Co.,Ltd · 2017
  • K111159Heartcheck Pen Handheld Ecg with Gems HomeCardiocomm Solutions, Inc. · 2011
  • K111438REKA E100Reka Pte, Ltd. · 2011

More from Cardiocomm Solutions, Inc.

9 FDA decisions under this applicant name. See the company

  • K181310HeartCheck Cardi Beat ECG Monitor with GEMS MobileCardiocomm Solutions, Inc. · 2019
  • K122632Guava IICardiocomm Solutions, Inc. · 2014
  • K111159Heartcheck Pen Handheld Ecg with Gems HomeCardiocomm Solutions, Inc. · 2011
  • K111320GlobalcardioCardiocomm Solutions, Inc. · 2011
  • K033037Modification to GlobalcardioCardiocomm Solutions, Inc. · 2003

Recent decisions in DPS

The DPS category page

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  • K260250QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)QT Medical, Inc. · 2026
  • K254255S-Patch CardioAIWellysis Corp. · 2026
  • K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc. · 2026

https://510kreport.com/device/K121009 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121009: Heartcheck Ecg Pen with Gems Home.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121009

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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