Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Merge Healthcare Incorporated · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
266 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250301 | Merge Universal Viewer (MUV) | Merge Healthcare Incorporated | 2025-04-14 | 73 | 0 |
| K233326 | Merge Hemo, Model RCSV2 | Merge Healthcare Incorporated | 2024-06-21 | 266 | 1 |
| K203104 | IBM iConnect Access | Merge Healthcare Incorporated | 2021-01-26 | 104 | 0 |
| K192455 | Merge PACS | Merge Healthcare Incorporated | 2019-10-17 | 38 | 2 |
| K192276 | Merge Cardio | Merge Healthcare Incorporated | 2019-09-20 | 29 | 0 |
| K182290 | IBM iConnect Access | Merge Healthcare Incorporated | 2018-09-25 | 33 | 0 |
| K173475 | Merge PACS | Merge Healthcare Incorporated | 2017-12-08 | 29 | 0 |
| K152864 | Merge Hemo | Merge Healthcare Incorporated | 2016-04-07 | 190 | 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