# K951902: Pathfinder 700 Holter Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Reynolds Medical, Ltd.
- Decided: Jul 15, 1996 after 448 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871344 (1987). 1 ancestor in all.
77 later devices descend from it; 3 cite it directly.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871344: Pathfinder 3, Auto Surveyor and Surveyor, Reynolds Medical, Ltd. (1987) Summary page 1.
- (no number) DelMar 263: named in the summary without a submission number
- (no number) Zymed 1510: named in the summary without a submission number

## Most influential descendants
- K990727: Syneflash & Syneview (1999), 68 descendants of its own
- K032466: Spiderview (2003), 56 descendants of its own
- K042108: Vista Plus (2005), 46 descendants of its own
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) (2007), 40 descendants of its own
- K071655: Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538 (2007), 30 descendants of its own

## Recalls of this device
- May 24, 2011 · Not classified · Z-2611-2011: 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.

## Indications for use
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).

Source page: https://510kreport.com/device/K951902
Methodology: https://510kreport.com/methodology