# K060919: Actical

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Sep 22, 2006 after 171 days
- Product code: GWK (Conditioner, Signal, Physiological)
- Device class: 2
- Regulation: 21 CFR 882.1845
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K914085 (1991). 6 ancestors in all.
36 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983533: Actiwatch, Mini-Mitter Co., Inc. (1999) Summary page 1.
- K011430: Actiware-PLMS, Mini-Mitter Co., Inc. (2001)
- K052489: Actiheart, Respironics, Inc. (2005) Summary page 1.

## Most influential descendants
- K122223: New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO (2013), 35 descendants of its own
- K151736: Philips IntelliVue GuardianSoftware (2015), 24 descendants of its own
- K161767: Philips IntelliVue GuardianSoftware (2017), 23 descendants of its own
- K132320: Intellivue CL Respiration Pod (2014), 20 descendants of its own
- K182543: Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package (2018), 19 descendants of its own

## Recalls of this device
- Jun 27, 2007 · Not classified · Z-0325-2008: 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 Actical is a compact, lightweight, waist-, wrist-, or ankle-worn activity monitor that may be used to assess human gross motor activity, caloric expenditure, and estimates of energy expenditure based on motor activity in any instance where quantifiable analysis of physical motion is desirable.

Source page: https://510kreport.com/device/K060919
Methodology: https://510kreport.com/methodology