Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medicel AG — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
234 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252540 | ACCUJECT Injector Set 2.1-1P (LP604590) | Medicel AG | 2025-09-16 | 35 | 0 |
| K231106 | Accuject Refra Injector AR2900 | Medicel AG | 2023-09-19 | 153 | 0 |
| K101134 | VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430 | Medicel AG | 2010-08-09 | 109 | 0 |
| K092023 | NAVIJECT SUB2-1P, MODEL: LP604430 | Medicel AG | 2009-07-28 | 22 | 0 |
| K070669 | IOL INJECTOR SET | Medicel AG | 2007-11-01 | 234 | 1 |
| K040837 | MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE | Medicel AG | 2004-06-17 | 78 | 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