510(k) · Cleared
ClearedREKA E100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reka Pte, Ltd. · DPS Electrocardiograph
Cleared on Sep 12, 2011 as substantially equivalent to K052303 (Dailycare Biomedical, Inc., 2005) and 3 other predicates after a 111-day review. Its family tree reaches back 4 generations to 1997. 32 later devices descend from it.
- Decided
- Sep 12, 2011
- Review
- 111 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K963725 (1997). 8 ancestors in all, the oldest K963811 (1996). 32 later devices descend from it, 1 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 deviceK111438 REKA E100Reka Pte, Ltd. · 2011
- Descendant · cites it directly · 31 of its ownK121628 Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013
- Descendant · 2 generations on · 30 of its ownK143513 ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015
- Descendant · 3 generations on · 18 of its ownK163512 Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · Recalled
- Descendant · 4 generations on · 12 of its ownK181502 Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · 2018
- Descendant · 5 generations on · 6 of its ownK210822 DeepRhythmAIMedicalgorithmics S.A. · 2022
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K121628Epi Mini Ecg Portable Health Monitoring System (Epi Mini)Epi Mobile Health Solutions (S) Pte, Ltd. · 2013 · cites it directly31descendants
- K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015 · 2 generations on30descendants
- K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · 3 generations on18descendants
- K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · 2018 · 4 generations on12descendants
- K210822DeepRhythmAIMedicalgorithmics S.A. · 2022 · 5 generations on6descendants
View 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) | K111438 | REKA E100 | Reka Pte, Ltd. | 2011 | — |
| +1 | K121628 | Epi Mini Ecg Portable Health Monitoring System (Epi Mini) | Epi Mobile Health Solutions (S) Pte, Ltd. | 2013 | — |
| +2 | K143513 | ZIO SR ECG Monitoring Service | iRhythm Technologies, Inc. | 2015 | — |
| +3 | K163512 | Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2017 | 1 |
| +4 | K181502 | Zio AT ECG Monitoring System, ZEUS System | iRhythm Technologies, Inc. | 2018 | — |
| +5 | K210822 | DeepRhythmAI | Medicalgorithmics S.A. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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? (4)
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 |
|---|---|---|---|
| * | K052303 | Readmyheart, Model RMH2.0Summary page 1…arketed Predicate devices to which this device is Substantially Equivalent: Predicate Device #1 Daily Care Biomedical, Inc. Model: ReadMylleart FDA 5 10(k): K052303 (2005) Predicate Device #2 Omron Corp. Model: HCG- 801 FDA 5 10O(k): K060766 (2006) Predicate Device #3 Card Guard Sc… | 2005 |
| * | K060766 | Portable, Electrocardiograph (Ecg) Monitor, Model HCG-801Summary page 1…evice #1 Daily Care Biomedical, Inc. Model: ReadMylleart FDA 5 10(k): K052303 (2005) Predicate Device #2 Omron Corp. Model: HCG- 801 FDA 5 10O(k): K060766 (2006) Predicate Device #3 Card Guard Scientific Survival, Ltd. Model: CG-6106 FDA 510(k): K(963811 (1996) Predicate Device #4… | 2006 |
| * | K963811 | Card Guard Model CG-6106 Personal Electrocardiogram (Ecg) Transmitter DeviceSummary page 1…cate Device #2 Omron Corp. Model: HCG- 801 FDA 5 10O(k): K060766 (2006) Predicate Device #3 Card Guard Scientific Survival, Ltd. Model: CG-6106 FDA 510(k): K(963811 (1996) Predicate Device #4 Beijing Choice Electronics Model: MD100 FDA 5 10(k): K(093872 (2010)… | 1996 |
| * | K093872 | Handheld Ecg Monitor, Model MD100Summary page 1…ate Device #3 Card Guard Scientific Survival, Ltd. Model: CG-6106 FDA 510(k): K(963811 (1996) Predicate Device #4 Beijing Choice Electronics Model: MD100 FDA 5 10(k): K(093872 (2010) Page 1 of 4… | 2010 |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121628 | Epi Mini Ecg Portable Health Monitoring System (Epi Mini) | 2013 | 31 |
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 8 ancestors has a recall.
- Of its descendants, K121628 (Epi Mobile Health Solutions (S) Pte, Ltd., 2013) has gone furthest, with 31 descendants of its own.
- 2 other devices also cite its predicate K052303.
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 REKA E100 EGG Event Recorder (Cardiac Rhythm Monitor) is intended for use by patients who may be at risk for experiencing transient cardiac symptoms that could suggest cardiac arrhythmia. The device records the patients EGG on demand at any time the patient feels any physical symptoms indicative of a potential heart event. A 30 second single channel ECG isrecorded and transmitted to a monitoring center. The monitoring center provides the EGG data to…
Read the full statement (248 words)
The REKA E100 EGG Event Recorder (Cardiac Rhythm Monitor) is intended for use by patients who may be at risk for experiencing transient cardiac symptoms that could suggest cardiac arrhythmia. The device records the patients EGG on demand at any time the patient feels any physical symptoms indicative of a potential heart event. A 30 second single channel ECG isrecorded and transmitted to a monitoring center. The monitoring center provides the EGG data to the medical practitioner for evaluation. The Indications for Use are the same as the predicate devices.
The device is a handheld, personal electrocardiograph unit, which can measure electrical activities of the heart easily and conveniently. It is immediately available at any time to manually record transient cardiac events, suitable for home health care use, and which can record and store an EGG signal, and then transmit the EGG recording to a hospital or cardiology center for interpretation and review.
It is suitable for adult users, who suffer from cardlo-vascular diseases, are considered at high risk for potential cardiovascular events or other adult people who are concerned about their heart function and rhythm as they move about during their daily life.
This device is not intended for use as a conventional diagnostic tool, but is to be used as a healthcare patient evaluation tool which can provide a doctor with the recorded EGG data as a reference to help detect and analyze heart events that a patient may experience at any time or any place.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111438 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111438: REKA E100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111438
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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