# K032466: Spiderview

- Pathway: 510(k) (Special)
- Applicant: Ela Medical, Inc.
- Decided: Aug 22, 2003 after 11 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K871344 (1987). 13 ancestors in all.
56 later devices descend from it; 4 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022540: Cardio ID+(RZ153+), Rozinn Electronics, Inc. (2002) Summary page 1.
- K993617: Digitrakplus Holter Recorder, Braemar Corp. (1999) Summary page 1.
- K990727: Syneflash & Syneview, Ela Medical, Inc. (1999) Summary page 1.

## Most influential descendants
- 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
- K103764: Reveal XT Insertable Cardiac Monitor, Model 9529 and Reveal DX Insertable Cardiac Monitor, Model 9528 (2011), 26 descendants of its own

## Indications for use
Recording of up to nine-channel surface ECG (Electrocardiogram) data from ambulatory patients during a 96-hour maximum period. High-resolution recording of surface ECG data. Note: Analysis of recorded Holter ECG data requires separately-supplied ELA Synetec, Syneview, or Synescope Holter analysis software.

Source page: https://510kreport.com/device/K032466
Methodology: https://510kreport.com/methodology