Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Icn Photonics , Ltd. · 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) |
|---|---|---|---|---|---|
| K024189 | NLITE SYSTEM, MODEL#: A00-1025/A00-1033 | Icn Photonics , Ltd. | 2003-06-20 | 183 | 0 |
| K020729 | NLITE SYSTEM,MODEL A00-1051 | Icn Photonics , Ltd. | 2002-06-04 | 90 | 0 |
| K013461 | NLITE SYSTEM,MODEL A00-1025 | Icn Photonics , Ltd. | 2002-01-17 | 91 | 0 |
| K014130 | NLITE SYSTEM | Icn Photonics , Ltd. | 2002-01-08 | 22 | 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