# K060167: Atria 3100, Atria 6100

- Pathway: 510(k) (Abbreviated)
- Applicant: Cardiac Science Corporation
- Decided: Apr 19, 2006 after 86 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). 5 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031422: Philips Page Writer Trim Series Cardiograph Including I, II, Iii, Models 860286, 860287, 860288, 860289, 860290, 860291, Philips Medical Systems (2003) Summary page 1.
- K050074: 12-Lead Resting Electrocardiograph, Models CP100 & CP200, Welch Allyn, Inc. (2005) Summary page 1.

## Most influential descendants
- K160876: PC ECG (2017), 8 descendants of its own
- K171942: Electrocardiograph (2018), 3 descendants of its own
- K170995: Electrocardiograph (2017), 3 descendants of its own
- K212278: Electrocardiograph (2022), 2 descendants of its own
- K222902: Electrocardiograph: SE-1200 Pro and SE-1201 Pro (2023), 1 descendant of its own

## Indications for use
Under the supervision of a qualified physician trained in EGG interpretation, Atria can be used to record the electrical activity of the heart for the purpose of correlating the resultant waveforms with the health of the heart muscle tissue structures. This equipment is not designed to produce a definitive interpretation nor exhaustive evaluation of the patient's heart but rather provide an effective beginning for evaluation of adult and pediatric patients with cardiac abnormalities.

Source page: https://510kreport.com/device/K060167
Methodology: https://510kreport.com/methodology