Infobionic, Inc.: FDA clearances and approvals
Infobionic, Inc. has 5 FDA 510(k) clearances (first 2014, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time: 172 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 284 |
| 2015 | 1 | 107 |
| 2016 | 1 | 58 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 248 |
| 2024 | 0 | — |
| 2025 | 1 | 172 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Infobionic, Inc.'s cleared 510(k)s took a median 210 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 240 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 3 | 3 |
| QYX | Outpatient Cardiac Telemetry | 2 | 2 |
Review panels
- Cardiovascular (5)
Most recent Infobionic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) | DSI | 2025-07-29 | 172 |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System | DSI | 2023-10-06 | 248 |
| K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System | QYX | 2016-03-11 | 58 |
| K152491 | MoMe Software Platform | DSI | 2015-12-17 | 107 |
| K133753 | MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR | QYX | 2014-09-19 | 284 |
Recalls
openFDA lists no recalls under a recalling firm named Infobionic, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Infobionic, Inc. have?
Infobionic, Inc. has 5 FDA 510(k) clearances (first 2014, latest 2025), across 2 product codes in 1 review panel.
How long does FDA take to clear Infobionic, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Infobionic, Inc.'s cleared 510(k)s is 172 days.
What devices does Infobionic, Inc. make?
Its most frequent FDA product codes are DSI (Detector And Alarm, Arrhythmia, 3); QYX (Outpatient Cardiac Telemetry, 2).
Has Infobionic, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Infobionic, Inc. Related entities may recall under other names.
Next steps
- See all 5 Infobionic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSI, Infobionic, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.