510(k) · Cleared
ClearedHeartcheck Pen Handheld Ecg with Gems Home
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiocomm Solutions, Inc. · DPS Electrocardiograph
Cleared on Dec 22, 2011 as substantially equivalent to K093872 (Beijing Choice Electronic Technololgy Co., Ltd., 2010) and 1 other predicate after a 241-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.
- Decided
- Dec 22, 2011
- Review
- 241 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K963725 (1997). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 3 generations backK012012 Ecg HomeH&C Medical Devices Spa · 2002
- 2 generations backK042814 ReadmyheartDailycare Biomedical, Inc. · 2005
- 1 generation backK052303 Readmyheart, Model RMH2.0Dailycare Biomedical, Inc. · 2005
- This deviceK111159 Heartcheck Pen Handheld Ecg with Gems HomeCardiocomm Solutions, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK181310 HeartCheck Cardi Beat ECG Monitor with GEMS MobileCardiocomm Solutions, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK121009 Heartcheck Ecg Pen with Gems HomeCardiocomm Solutions, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −3 | K012012 | Ecg Home | H&C Medical Devices Spa | 2002 | — |
| −2 | K042814 | Readmyheart | Dailycare Biomedical, Inc. | 2005 | — |
| −1 | K052303 | Readmyheart, Model RMH2.0 | Dailycare Biomedical, Inc. | 2005 | — |
| 0 (this device) | K111159 | Heartcheck Pen Handheld Ecg with Gems Home | Cardiocomm Solutions, Inc. | 2011 | — |
| +1 | K181310 | HeartCheck Cardi Beat ECG Monitor with GEMS Mobile | Cardiocomm Solutions, Inc. | 2019 | — |
| +1 | K121009 | Heartcheck Ecg Pen with Gems Home | Cardiocomm Solutions, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K093872 | Handheld Ecg Monitor, Model MD100Summary page 2…device has low battery voltage indication function. 2 AAA batteries supply the power for the monitor. Predicate Device(s): Handheld ECG Monitor MD 100 (K093872) Read My Heart Model RMH 2.0 (K052303) Substantial Equivalence:… | 2010 |
| * | K052303 | Readmyheart, Model RMH2.0Summary page 2…the power for the monitor. Predicate Device(s): Handheld ECG Monitor MD 100 (K093872) Read My Heart Model RMH 2.0 (K052303) Substantial Equivalence: 6I e" c3 The proposed device is subs… | 2005 |
What descends from it? (2)
2 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)
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 14 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K181310 (Cardiocomm Solutions, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K093872.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 HeartCheckTM Pen Handheld with GEMS Home software is an over-the-counter device intended to record, store, transfer single channel Heart Rhythm signals and, for users under a physician's care, display Heart Rhythm waveforms. The HeartCheckTM Pen Handheld device along with GEMS Home software is not intended to substitute a hospital diagnostic ECG device. The device is not intended for simultaneously recording and transmitting a user's Heart Rhythm. Users with an implanted pacemaker or a defibrillator are not recommended to use this device. GEMS Home is a simple software user interface for managing Heart Rhythm recordings and associated data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111159: Heartcheck Pen Handheld Ecg 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/K111159
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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