# K193177: CER-S

- Pathway: 510(k) (Traditional)
- Applicant: Cardiocalm
- Decided: Aug 26, 2020 after 282 days
- Product code: MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930806 (1994). 22 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042002: Synescope, Easyscope, Synecom, Holterreader, Ela Medical, Inc. (2004) Summary page 4.

## Most influential descendants
- K213861: CER-S (2022), 1 descendant of its own
- K243312: CER-S (2025), 0 descendants of its own

## Indications for use
CER-S is a stand-alone software medical device intended to analyze, edit, review and report digital continuous ECG recordings. 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. The device provides the clinician an additional tool to aid in the interpretation of ECG data for diagnosis of heart rhythm disorders in adult and pediatric patients. Note: 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, but not limited to, 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/K193177
Methodology: https://510kreport.com/methodology