# K072353: Portable Ecscope

- Pathway: 510(k) (Traditional)
- Applicant: Dyansys Corp
- Decided: Aug 30, 2007 after 8 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: 3 generations back to K895520 (1990). 6 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954980: Pagewriter 200, 200I Cardiograph & Interpretive Cardio, Hewlett-Packard Co. (1996) Summary page 1.
- K032200: Elan Digital 12 Channel Electrocardiograph, Remco Italia S.P.A. (2003) Summary page 1.

## Most influential descendants
- K080036: Portable Ecscope 12I (2008), 2 descendants of its own
- K082013: Clue Medical and Clue Medical Basic (2008), 1 descendant of its own
- K091397: Ecscope 200 (2009), 0 descendants of its own
- K091358: Ecscope 100 (2009), 0 descendants of its own
- K083630: Clue Medical and Clue Medical Basic (2009), 0 descendants of its own

## Indications for use
The Portable ECScope handheld, battery operated Multi channel electrocardiograph is intended to be used for evaluation of the cardiovascular system. The Portable ECScope will acquire, display and record Multi channel ECG signals. The Portable ECScope is intended to be used by a licensed health care practitioner or under the direct supervision of a licensed health care practitioner in a hospital or health care environment. These measurements are not intended for specific clinical diagnosis. The clinical significance must be determined by a physician.

Source page: https://510kreport.com/device/K072353
Methodology: https://510kreport.com/methodology