# K990727: Syneflash & Syneview

- Pathway: 510(k) (Traditional)
- Applicant: Ela Medical, Inc.
- Decided: Nov 26, 1999 after 266 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K871344 (1987). 8 ancestors in all.
68 later devices descend from it; 3 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942565: Altair-Disc Recorder, Burdick Corp. (1994) Summary page 1.
- K945130: Braemar Model DL700 Ambulatory Electrocardiographic Recorder, Braemar Corp. (1995) Summary page 1.
- K970902: Medilog FD4, Oxford Instruments Medical Systems (1997) Summary page 1.
- K895806: Elatec Holter Analyzer, Ela Medical, Inc. (1990) Summary page 1.
- K945985: PC Holter Scanning System Simplicity, Altair 8200, 8300, 8400, Burdick, Inc. (1995) Summary page 1.
- K951902: Pathfinder 700 Holter Analyzer, Reynolds Medical, Ltd. (1996) Summary page 1.

## Most influential descendants
- 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
- K082475: Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor, Model 9528 (2008), 28 descendants of its own

## Indications for use
Recording of two- or three-channel surface ECG (Electrocardiogram) data from ambulatory patients during a 24-hour period. High-resolution recording of surface ECG data. Analysis of recorded Holter ECG data.

Source page: https://510kreport.com/device/K990727
Methodology: https://510kreport.com/methodology