510(k) · Cleared
ClearedHolter Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rozinn Electronics, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Sep 22, 2004 as substantially equivalent to K930564 (North East Monitoring, Inc., 1995) and 4 other predicates after a 9-day review. Its family tree reaches back 1 generation to 1988. 35 later devices descend from it.
- Decided
- Sep 22, 2004
- Review
- 9 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to K881905 (1988). 5 ancestors in all. 35 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK881905 Model Micro SI Ambulatory Ecg MonitorAdvanced Medical Products, Inc. · 1988
- This deviceK042463 Holter PlusRozinn Electronics, Inc. · 2004
- Descendant · cites it directly · 32 of its ownK091075 Zeus (Zio Ecg Utilization Service) SystemiRhythm Technologies, Inc. · 2009
- Descendant · 2 generations on · 31 of its ownK142681 ZEUS (ZIO ECG Utilization Service) SystemiRhythm Technologies, Inc. · 2014
- Descendant · 3 generations on · 30 of its ownK143513 ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015
- Descendant · 4 generations on · 18 of its ownK163512 Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · Recalled
- Descendant · 5 generations on · 12 of its ownK181502 Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · 2018
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K091075Zeus (Zio Ecg Utilization Service) SystemiRhythm Technologies, Inc. · 2009 · cites it directly32descendants
- K142681ZEUS (ZIO ECG Utilization Service) SystemiRhythm Technologies, Inc. · 2014 · 2 generations on31descendants
- K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015 · 3 generations on30descendants
- K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · 4 generations on18descendants
- K181502Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · 2018 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881905 | Model Micro SI Ambulatory Ecg Monitor | Advanced Medical Products, Inc. | 1988 | — |
| 0 (this device) | K042463 | Holter Plus | Rozinn Electronics, Inc. | 2004 | — |
| +1 | K091075 | Zeus (Zio Ecg Utilization Service) System | iRhythm Technologies, Inc. | 2009 | — |
| +2 | K142681 | ZEUS (ZIO ECG Utilization Service) System | iRhythm Technologies, Inc. | 2014 | — |
| +3 | K143513 | ZIO SR ECG Monitoring Service | iRhythm Technologies, Inc. | 2015 | — |
| +4 | K163512 | Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2017 | 1 |
| +5 | K181502 | Zio AT ECG Monitoring System, ZEUS System | iRhythm Technologies, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K930564 | Holter for WindowsSummary page 1…on: Class II (see 21 CFR - 870.1425) Predicate Devices: The predicate device(s) are the following: 1. Northeast Monitoring Inc. Holter for Windows System (5 10(k) K930564). 2. Caird Technology Bolter 2000 System. (510(k) K012686). 3. Advanced BioSensor ABS Bolter (formerly Micro SI Ambulator… | 1995 |
| * | K012686 | Caird Technology Holter 2000Summary page 1…predicate device(s) are the following: 1. Northeast Monitoring Inc. Holter for Windows System (5 10(k) K930564). 2. Caird Technology Bolter 2000 System. (510(k) K012686). 3. Advanced BioSensor ABS Bolter (formerly Micro SI Ambulatory ECU Monitor) System (5 10(k) K881905). 4. Oxford… | 2001 |
| * | K881905 | Model Micro SI Ambulatory Ecg MonitorSummary page 1…64). 2. Caird Technology Bolter 2000 System. (510(k) K012686). 3. Advanced BioSensor ABS Bolter (formerly Micro SI Ambulatory ECU Monitor) System (5 10(k) K881905). 4. Oxford Scientific Medilog Excel 2 System. (5 10(k) K002544). 5. Biomed Systems Inc. WinPV Bolter System. (510(k) K88… | 1988 |
| * | K002544 | Medilog Excel 2 - Holter Management SystemSummary page 1…3. Advanced BioSensor ABS Bolter (formerly Micro SI Ambulatory ECU Monitor) System (5 10(k) K881905). 4. Oxford Scientific Medilog Excel 2 System. (5 10(k) K002544). 5. Biomed Systems Inc. WinPV Bolter System. (510(k) K8841524). These predicate devices have the same performance specifica… | 2000 |
| * | K884152 | Century Color TraceSummary page 1…ECU Monitor) System (5 10(k) K881905). 4. Oxford Scientific Medilog Excel 2 System. (5 10(k) K002544). 5. Biomed Systems Inc. WinPV Bolter System. (510(k) K8841524). These predicate devices have the same performance specifications as the Holter PlusTM Ambulatory ECG Analysis System Device… | 1988 |
What descends from it? (35)
See all 352 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?
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The Holter PlusTM Ambulatory ECG Analysis System is intended for general hospital or clinical use by medical professionals whenever it is required to assess a patient's ambulatory ECG data. This product allows a trained physician or health care professional, after having performed a long-term continuous electrocardiograph (ECG) recording on a digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce…
Read the full statement (165 words)
The Holter PlusTM Ambulatory ECG Analysis System is intended for general hospital or clinical use by medical professionals whenever it is required to assess a patient's ambulatory ECG data. This product allows a trained physician or health care professional, after having performed a long-term continuous electrocardiograph (ECG) recording on a digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports. This will enable the evaluation of arrhythmias, ischemic attacks, reporting of PQRST intervals, clinical and epidemiological research studies, evaluation of a patients response after resuming occupational or recreational activities (e.g., after MI. or cardiac surgery, and/or evaluation of patients with pacemakers.
The need to record, review, edit and archive these ambulatory ECG data is most commonly encountered in the Cardiology areas of the hospital during cardiac patient assessment. This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042463 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042463: Holter Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042463
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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