# K082013: Clue Medical and Clue Medical Basic

- Pathway: 510(k) (Traditional)
- Applicant: Telovital GmbH Telemedizin
- Decided: Nov 10, 2008 after 118 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K895520 (1990). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072353: Portable Ecscope, Dyansys Corp (2007) Summary page 1.
- K060766: Portable,  Electrocardiograph (Ecg) Monitor, Model HCG-801, Omron Healthcare, Inc. (2006) Summary page 1.
- K050670: Sensor Mobile SM 100 Vitaphone 1001R Remos, Tms Telemedizinische Systeme GmbH (2005) Summary page 2.

## Most influential descendants
- K083630: Clue Medical and Clue Medical Basic (2009), 0 descendants of its own

## Indications for use
The clue medical and clue medical BASIC are handheld, battery operated single channel electrocardiographs intended for recording and transmitting ECG data by patients who are concerned about their heart rhythm. The clue medical and clue medical BASIC allow the patient to record their ECG data into the device memory and transmit it for display by healthcare professionals. Specifically, the clue medical and clue medical BASIC are intended for patients that are concerned about their heart rhythm or have experienced the following symptoms that are suggestive of abnormal heart rhythm: Skipped beats Pounding heart (palpitations) History of arrhythmia The clue medical and clue medical BASIC ECG data is intended to be used by a licensed health care practitioner. These measurements are not intended for any specific clinical diagnosis. The clinical significance must be determined by the physician.

Source page: https://510kreport.com/device/K082013
Methodology: https://510kreport.com/methodology