510(k) · Cleared
ClearedFidelity 200 Cardiac Event Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signalife, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Nov 21, 2007 as substantially equivalent to K010945 (Instromedix, 2001) and 2 other predicates after a 202-day review. Its family tree reaches back 2 generations to 1997. 32 later devices descend from it.
- Decided
- Nov 21, 2007
- Review
- 202 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K963725 (1997). 3 ancestors in all. 32 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 1 generation backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- This deviceK071228 Fidelity 200 Cardiac Event RecorderSignalife, Inc. · 2007
- 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 |
|---|---|---|---|---|---|
| −2 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −1 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| 0 (this device) | K071228 | Fidelity 200 Cardiac Event Recorder | Signalife, Inc. | 2007 | — |
| +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 |
|---|---|---|
| 2001 | 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 DXH? 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 DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 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? (3)
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 |
|---|---|---|---|
| * | K010945 | Heartcard, Model 5258Summary page 1…s equivalent to: * HeartCard(& Telephone Electrocardiograh Transmitter and Receiver, KO010945, Instromedix, hic. * Card Guard CG-2206 1-Lead ECG Event Recorder, K96… | 2001 |
| * | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified)Summary page 1…Receiver, KO010945, Instromedix, hic. * Card Guard CG-2206 1-Lead ECG Event Recorder, K963725, Instromedix, Inc. * CG-221 1 Self Check ECG Transmitter, K0 12223, Card… | 1997 |
| * | K012223 | CG-2211 Selfcheck Ecg TransmitterSummary page 1…ard Guard CG-2206 1-Lead ECG Event Recorder, K963725, Instromedix, Inc. * CG-221 1 Self Check ECG Transmitter, K0 12223, Card Guard Scientific Survival, LTD 4. Intended Use: The Signalife Fidel… | 2001 |
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 10 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- None of the 3 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.
- 3 other devices also cite its predicate K010945.
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, 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 | 3 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Signalife Fidelity 200 Cardiac Event Recorder is a battery operated; user-activated ECG event recorder and transmitter intended to record an ECG by patients who subscribe for the service. This allows users to record and transmit their ECG data to medical professionals via a communication device to a cardiac monitoring center. The Signalife Fidelity 200 Cardiac Event Recorder is intended for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal cardiac rhythms:
Skipped beats, Pounding heart (Palpitations), Heart racing or irregular pulse, Lightheadedness or Faintness, History of Arrhythmia
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071228 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071228: Fidelity 200 Cardiac Event Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071228
Report an extraction error
Are you the manufacturer?
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