# K945985: PC Holter Scanning System Simplicity, Altair 8200, 8300, 8400

- Pathway: 510(k) (Traditional)
- Applicant: Burdick, Inc.
- Decided: Jul 3, 1995 after 207 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
No predicates in its family tree.
72 later devices descend from it; 2 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K945985
Methodology: https://510kreport.com/methodology