Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Planar Systems, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061018 | PLANAR DOME EX LINE MODEL DOME E2C | Planar Systems, Inc. | 2006-04-28 | 15 | 0 |
| K060136 | PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MOD | Planar Systems, Inc. | 2006-01-31 | 12 | 0 |
| K032638 | DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AN | Planar Systems, Inc. | 2003-09-11 | 15 | 0 |
| K032202 | DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I | Planar Systems, Inc. | 2003-08-01 | 14 | 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