Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medeon Biodesign, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
234 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200902 | ClickClean | Medeon Biodesign, Inc. | 2020-04-30 | 27 | 0 |
| K193652 | AbClose - Port Site Closure Device | Medeon Biodesign, Inc. | 2020-03-26 | 87 | 0 |
| K192891 | Laparoscope Lens Shield Device (LENS) | Medeon Biodesign, Inc. | 2019-11-07 | 28 | 0 |
| K170103 | Laparoscope Lens Shield Device (LENS) | Medeon Biodesign, Inc. | 2017-02-16 | 35 | 0 |
| K160117 | AbClose - Port Site Closure Device | Medeon Biodesign, Inc. | 2016-09-09 | 234 | 0 |
| K160172 | Laparoscope Lens Shield Device | Medeon Biodesign, Inc. | 2016-04-21 | 85 | 0 |
| K151117 | Laparoscope Lens Shield Device | Medeon Biodesign, Inc. | 2015-08-20 | 115 | 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