Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Infobionic, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
172 daysmedian FDA review time
284 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection S | Infobionic, Inc. | 2025-07-29 | 172 | 0 |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection S | Infobionic, Inc. | 2023-10-06 | 248 | 0 |
| K160064 | MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection | Infobionic, Inc. | 2016-03-11 | 58 | 0 |
| K152491 | MoMe Software Platform | Infobionic, Inc. | 2015-12-17 | 107 | 0 |
| K133753 | MOME ECG CONTINUOUS DETECTION AND ARRHYTHMIA DETECTOR | Infobionic, Inc. | 2014-09-19 | 284 | 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