# K854030: Wrist Actigraph

- Pathway: 510(k) (Traditional)
- Applicant: Ambulatory Monitoring, Inc.
- Decided: Jun 25, 1986 after 267 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
129 later devices descend from it; 3 cite it directly.
0 of 130 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
- K983533: Actiwatch (1999), 126 descendants of its own
- K992410: Actitrac (1999), 73 descendants of its own
- K071641: Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539) (2007), 40 descendants of its own
- K060919: Actical (2006), 36 descendants of its own
- K122223: New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO (2013), 35 descendants of its own

Source page: https://510kreport.com/device/K854030
Methodology: https://510kreport.com/methodology