# K991045: Mini-Logger Series 2000

- Pathway: 510(k) (Traditional)
- Applicant: Mini-Mitter Co., Inc.
- Decided: Sep 21, 1999 after 176 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: 1 generation back to K914085 (1991). 1 ancestor in all.
138 later devices descend from it; 2 cite it directly.
0 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914085: HMS-5000, Vitalog Monitoring,Inc. (1991) Summary page 1.

## Most influential descendants
- K052489: Actiheart (2005), 132 descendants of its own
- 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

## Indications for use
The Mini-Logger® Series 2000 (hereafter referred to as Mini-Logger) is a compact, lightweight, physiological data logger for monitoring heart rate, inter-beat-interval (IBI), temperature, ambient light, and activity. The Mini-Logger® can be used in behavioral and circadian rhythm studies, sleep research, occupational health and sports medicine research, and obesity/weight loss studies. The device can be used for any assessment of human heart rate or IBI, temperature, and activity that requires logging of data over time and an integrated analysis of the aforementioned parameters. The Mini-Logger® may be used in any instance where quantifiable analysis of physiological data is desirable.

Source page: https://510kreport.com/device/K991045
Methodology: https://510kreport.com/methodology