# K243312: CER-S

- Pathway: 510(k) (Traditional)
- Applicant: Cardiocalm Srl
- Decided: Feb 20, 2025 after 121 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K930806 (1994). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213861: CER-S, Cardiocalm Srl (2022) Summary page 5.

## Indications for use
CER-S is a medical device stand-alone software intended for the analysis, editing, review and reporting of continuous ECG digital recordings, to support the clinician in the interpretation of the trace and the diagnosis of cardiac rhythm disorders in adult and pediatric patients. CER-S is intended for use in clinical and hospital settings only by qualified medical personnel or adequately trained professional personnel working under the supervision and responsibility of a clinician. Users must undergo a thorough software training before using the medical device. This device does not provide an automated interpretation and is not intended for use as the only diagnostic tool. CER-S analysis provides indications for evaluation of: * Patients with rhythm disturbances (cardiac arrhythmias), * Patients with transient myocardial ischemia, * Patients with pacemaker (only if pacing detection is available from the input recording), * Patients needing HRV evaluation, * Newborn patients limited to QRS detection.

Source page: https://510kreport.com/device/K243312
Methodology: https://510kreport.com/methodology