# K103640: Midmark Iqecg

- Pathway: 510(k) (Traditional)
- Applicant: Brentwood Medical Technology Corp.
- Decided: Mar 22, 2011 after 99 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955023 (1997). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955023: Brentwood PC-Ecg, Brentwood Medical Products, Inc. (1997) Summary page 1.

## Most influential descendants
- K143436: InvisionECG System (2015), 0 descendants of its own
- K123217: Cardeascreen (2013), 0 descendants of its own
- K113234: Mobcardio System (2011), 0 descendants of its own

## Recalls of this device
- Jul 20, 2026 · Class II · Z-3012-2026: A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.

## Indications for use
The Midmark IQecg is indicated for use, under the supervision of a Physician, to obtain electrocardiograms from the adult and pediatric human body surface. The process of taking an electrocardiogram is non-invasive, painless, without direct risk to the patient and is reproducible.

Source page: https://510kreport.com/device/K103640
Methodology: https://510kreport.com/methodology