# K010505: Telemed 12 Lead Resting Ecg Analysis Library

- Pathway: 510(k) (Special)
- Applicant: Brentwood Medical Technology Corp.
- Decided: Mar 9, 2001 after 16 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K032200: Elan Digital 12 Channel Electrocardiograph (2003), 6 descendants of its own
- K072353: Portable Ecscope (2007), 5 descendants of its own
- 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

Source page: https://510kreport.com/device/K010505
Methodology: https://510kreport.com/methodology