Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medicalgorithmics S.A. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
194 daysmedian FDA review time
444 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253141 | DeepRhythmAI | Medicalgorithmics S.A. | 2025-12-11 | 77 | 0 |
| K250932 | DeepRhythmAI | Medicalgorithmics S.A. | 2025-05-27 | 60 | 0 |
| K241197 | DeepRhythmAI | Medicalgorithmics S.A. | 2024-12-04 | 218 | 0 |
| K232161 | DeepRhythm Platform | Medicalgorithmics S.A. | 2024-06-20 | 336 | 0 |
| K210822 | DeepRhythmAI | Medicalgorithmics S.A. | 2022-07-27 | 495 | 0 |
| K210758 | Q Patch | Medicalgorithmics S.A. | 2022-06-02 | 444 | 0 |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IV | Medicalgorithmics S.A. | 2020-04-09 | 153 | 0 |
| K173969 | Medicalgorithmics Unified Cardiac Rehabilitation System | Medicalgorithmics S.A. | 2018-07-11 | 194 | 0 |
| K152550 | MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM | Medicalgorithmics S.A. | 2015-10-08 | 30 | 0 |
| K124060 | MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM | Medicalgorithmics S.A. | 2013-02-21 | 52 | 0 |
| K112921 | MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM | Medicalgorithmics S.A. | 2012-05-16 | 226 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda