Medicalgorithmics S.A.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Medicalgorithmics S.A.” (first 2012, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 194 days. Since 2017 the median was 206 days, against 161 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 226 |
| 2013 | 1 | 52 |
| 2014 | 0 | — |
| 2015 | 1 | 30 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 194 |
| 2019 | 0 | — |
| 2020 | 1 | 153 |
| 2021 | 0 | — |
| 2022 | 2 | 470 |
| 2023 | 0 | — |
| 2024 | 2 | 277 |
| 2025 | 2 | 68 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medicalgorithmics S.A. took a median 206 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 161 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 5 | 5 |
| DQK | Computer, Diagnostic, Programmable | 4 | 4 |
| DPS | Electrocardiograph | 1 | 1 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 1 | 1 |
Review panels
- Cardiovascular (11)
Most recent Medicalgorithmics S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253141 | DeepRhythmAI | DQK | 2025-12-11 | 77 |
| K250932 | DeepRhythmAI | DQK | 2025-05-27 | 60 |
| K241197 | DeepRhythmAI | DQK | 2024-12-04 | 218 |
| K232161 | DeepRhythm Platform | DPS | 2024-06-20 | 336 |
| K210822 | DeepRhythmAI | DQK | 2022-07-27 | 495 |
| K210758 | Q Patch | MWJ | 2022-06-02 | 444 |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IV | DSI | 2020-04-09 | 153 |
| K173969 | Medicalgorithmics Unified Cardiac Rehabilitation System | DSI | 2018-07-11 | 194 |
| K152550 | MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM | DSI | 2015-10-08 | 30 |
| K124060 | MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM | DSI | 2013-02-21 | 52 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medicalgorithmics S.A..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medicalgorithmics SP Z.O.O. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medicalgorithmics S.A.?
FDA lists 11 510(k) clearances under the applicant name “Medicalgorithmics S.A.” (first 2012, latest 2025), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medicalgorithmics S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medicalgorithmics S.A. is 194 days. Since 2017: 206 days, versus 161 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medicalgorithmics S.A.?
The most frequent FDA product codes under this applicant name are DSI (Detector And Alarm, Arrhythmia, 5); DQK (Computer, Diagnostic, Programmable, 4); DPS (Electrocardiograph, 1).
Next steps
- See all 11 Medicalgorithmics S.A. clearances with predicates and recalls
- Run predicate analysis for product code DSI, Medicalgorithmics S.A.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.