Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Merlin Engineering Works, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
638 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974882 | DOWNSCAN LT | Merlin Engineering Works, Inc. | 1998-05-22 | 143 | 0 |
| K971154 | MULTIPICS(ME-977) | Merlin Engineering Works, Inc. | 1997-06-25 | 89 | 0 |
| K971153 | SPLITSCREEN (ME-975) | Merlin Engineering Works, Inc. | 1997-06-25 | 89 | 0 |
| K970451 | DOWNSCAN 120 | Merlin Engineering Works, Inc. | 1997-04-07 | 60 | 0 |
| K970450 | UPSCAN 120 | Merlin Engineering Works, Inc. | 1997-04-01 | 54 | 0 |
| K954211 | CRISPICS | Merlin Engineering Works, Inc. | 1995-12-05 | 89 | 0 |
| K953398 | UNISCAN | Merlin Engineering Works, Inc. | 1995-10-06 | 78 | 0 |
| K933512 | UPSCAN | Merlin Engineering Works, Inc. | 1995-04-19 | 638 | 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