510(k) · Cleared
ClearedCaird Technology Holter 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caird Technology · DPS Electrocardiograph
Cleared on Dec 13, 2001 after a 121-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 38 later devices descend from it.
- Decided
- Dec 13, 2001
- Review
- 121 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 0
38 later devices descend from it, 2 citing it directly.
- This deviceK012686 Caird Technology Holter 2000Caird Technology · 2001
- Descendant · cites it directly · 35 of its ownK042463 Holter PlusRozinn Electronics, Inc. · 2004
- Descendant · 2 generations on · 32 of its ownK091075 Zeus (Zio Ecg Utilization Service) SystemiRhythm Technologies, Inc. · 2009
- Descendant · 3 generations on · 31 of its ownK142681 ZEUS (ZIO ECG Utilization Service) SystemiRhythm Technologies, Inc. · 2014
- Descendant · 4 generations on · 30 of its ownK143513 ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015
- Descendant · 5 generations on · 18 of its ownK163512 Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · Recalled
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K042463Holter PlusRozinn Electronics, Inc. · 2004 · cites it directly35descendants
- K091075Zeus (Zio Ecg Utilization Service) SystemiRhythm Technologies, Inc. · 2009 · 2 generations on32descendants
- K142681ZEUS (ZIO ECG Utilization Service) SystemiRhythm Technologies, Inc. · 2014 · 3 generations on31descendants
- K143513ZIO SR ECG Monitoring ServiceiRhythm Technologies, Inc. · 2015 · 4 generations on30descendants
- K163512Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · 5 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012686 | Caird Technology Holter 2000 | Caird Technology | 2001 | — |
| +1 | K042463 | Holter Plus | Rozinn Electronics, Inc. | 2004 | — |
| +2 | K091075 | Zeus (Zio Ecg Utilization Service) System | iRhythm Technologies, Inc. | 2009 | — |
| +3 | K142681 | ZEUS (ZIO ECG Utilization Service) System | iRhythm Technologies, Inc. | 2014 | — |
| +4 | K143513 | ZIO SR ECG Monitoring Service | iRhythm Technologies, Inc. | 2015 | — |
| +5 | K163512 | Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (38)
See all 382 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?
- Of its descendants, K042463 (Rozinn Electronics, Inc., 2004) has gone furthest, with 35 descendants of its own.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Designed for Adult and Pediatric Patients. For Hospital and Clinic use only. Some of the conditions for use are as follows: Evaluation of Symptoms suggesting arrhythmia or myocardial ischemia. Evaluation of ECG documentation therapeutic intervention in individual or groups of patients. Evaluation of patieats for ST segment Changes Evaluation of patients response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery).…
Read the full statement (110 words)
Designed for Adult and Pediatric Patients.
For Hospital and Clinic use only.
Some of the conditions for use are as follows:
Evaluation of Symptoms suggesting arrhythmia or myocardial ischemia.
Evaluation of ECG documentation therapeutic intervention in individual or groups of patients.
Evaluation of patieats for ST segment Changes
Evaluation of patients response after resuming occupational or recreational activities (e.g. after M.I. or cardiac surgery).
Evaluation of clinical syndromes or situations where arrhythmia may increase the risk of sudden death.
Clinical and epidemiological research studies.
Precaution:
Computerized ECG Analysis should not replace diagnosis by a qualified physician. The physician should verify that the reported data is accurate before applying clinical conclusions.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012686 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012686: Caird Technology Holter 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012686
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026