# K052489: Actiheart

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Sep 27, 2005 after 15 days
- Product code: GWK (Conditioner, Signal, Physiological)
- Device class: 2
- Regulation: 21 CFR 882.1845
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K914085 (1991). 2 ancestors in all.
132 later devices descend from it; 6 cite it directly.
0 of 135 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991045: Mini-Logger Series 2000, Mini-Mitter Co., Inc. (1999) Summary page 2.

## Most influential descendants
- K061993: Equivital, Model EQ-01 (2006), 99 descendants of its own
- K113054: Equivital (2012), 71 descendants of its own
- K141167: Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and Secure Server Software Library) (2014), 70 descendants of its own
- K152139: Vital Connect Platform, HealthPatch MD, VitalPatch (2015), 43 descendants of its own
- K060919: Actical (2006), 36 descendants of its own

## Indications for use
The Actiheart is an ambulatory Heart Rate and Activity Recorder. Actiheart may be used to quantifiably measure Heart Rate, Activity, and estimates of Caloric Expenditure. This device is not intended for use as an ECG monitor.

Source page: https://510kreport.com/device/K052489
Methodology: https://510kreport.com/methodology