# K983533: Actiwatch

- Pathway: 510(k) (Traditional)
- Applicant: Mini-Mitter Co., Inc.
- Decided: Mar 23, 1999 after 166 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K854030 (1986). 1 ancestor in all.
126 later devices descend from it; 6 cite it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854030: Wrist Actigraph, Ambulatory Monitoring, Inc. (1986) Summary page 1.
- (no number) Mini-Motionlogger Actigraph: named in the summary without a submission number

## Most influential descendants
- 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
- K991033: Actiwatch-Score (1999), 35 descendants of its own

## Recalls of this device
- Jun 27, 2007 · Not classified · Z-0324-2008: Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communica
- Jun 27, 2007 · Not classified · Z-0326-2008: Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communica
- Jun 27, 2007 · Not classified · Z-0327-2008: Communication Failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communica

## Indications for use
The Actiwatch® is an ultra-compact, lightweight, wrist-worn activity and ambient light monitor that can be used to analyze circadian rhythms, automatically collect and score data for sleep parameters, and assess activity in any instance where quantifiable analysis of physical motion is desirable.

Source page: https://510kreport.com/device/K983533
Methodology: https://510kreport.com/methodology