510(k) · Cleared
Recalled · 2011Pathfinder 700 Holter Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reynolds Medical, Ltd. · DQK Computer, Diagnostic, Programmable
Cleared on Jul 15, 1996 as substantially equivalent to K871344 (Reynolds Medical, Ltd., 1987) after a 448-day review. Its family tree reaches back 1 generation to 1987. 77 later devices descend from it. It has been recalled once.
- Decided
- Jul 15, 1996
- Review
- 448 days
- Class
- Class II
- Product code
- DQK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K871344 (1987). 77 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK871344 Pathfinder 3, Auto Surveyor and SurveyorReynolds Medical, Ltd. · 1987
- This deviceK951902 Pathfinder 700 Holter AnalyzerReynolds Medical, Ltd. · 1996
- Descendant · cites it directly · 68 of its ownK990727 Syneflash & SyneviewEla Medical, Inc. · 1999
- Descendant · 2 generations on · 56 of its ownK032466 SpiderviewEla Medical, Inc. · 2003
- Descendant · 3 generations on · 46 of its ownK042108 Vista PlusNovacor · 2005
- Descendant · 4 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
- Descendant · 4 generations on · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K990727Syneflash & SyneviewEla Medical, Inc. · 1999 · cites it directly68descendants
- K032466SpiderviewEla Medical, Inc. · 2003 · 2 generations on56descendants
- K042108Vista PlusNovacor · 2005 · 3 generations on46descendants
- K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 4 generations on40descendants
- K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · 4 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871344 | Pathfinder 3, Auto Surveyor and Surveyor | Reynolds Medical, Ltd. | 1987 | — |
| 0 (this device) | K951902 | Pathfinder 700 Holter Analyzer | Reynolds Medical, Ltd. | 1996 | — |
| +1 | K990727 | Syneflash & Syneview | Ela Medical, Inc. | 1999 | — |
| +2 | K032466 | Spiderview | Ela Medical, Inc. | 2003 | — |
| +3 | K042108 | Vista Plus | Novacor | 2005 | — |
| +4 | K071641 | Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model… | Medtronic, Inc. | 2007 | — |
| +4 | K071655 | Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)… | Medtronic, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 6 | 0 |
| 2017 | 6 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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? (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 |
|---|---|---|---|
| * | K871344 | Pathfinder 3, Auto Surveyor and SurveyorSummary page 1…rrhythmia Detector and Alarm (3) Predicate Devices: The principal predicate device is the Reynolds Pathfinder 3, which received marketing permission from the FDA under K871344 on October 20, 1987. The principal modification of the Pathfinder 7¢0 is the use of modern, high-speed, digital technology. Othe… | 1987 |
| * | — | DelMar 263 Named without a submission number | |
| * | — | Zymed 1510 Named without a submission number |
What descends from it? (77)
See all 773 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 24, 2011 | Not classified | Z-2611-2011 | Software design | A potential hazard associated with the use of Spacelabs Healthcare Pathfinder Holter Analyzer software. The second 24 hours of a 48 hours EVO recording will not be analyzed. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K990727 (Ela Medical, Inc., 1999) has gone furthest, with 68 descendants of its own.
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 Reynolds Pathfinder 700 Holter Analyzer is intended to be used to analyze magnetic tapes of ambulatory electrocardiograms made on compatible Holter Recorders. The system will detect various arrhythmias and will measure ST elevation or depression. The system acts in both an automatic mode (tape analyzed without operator intervention) and in an interactive mode (operator can intervene and affect analysis).
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/K951902 · printed Nov 4, 2026
Cite this page
510(k) Report. “K951902: Pathfinder 700 Holter Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951902
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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