Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Konan Medical, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
211 daysmedian FDA review time
525 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203244 | CellChek 20 rc | Konan Medical, Inc. | 2021-06-15 | 224 | 0 |
| K191558 | Konan Specular Microscope XVII | Konan Medical, Inc. | 2020-03-26 | 288 | 0 |
| K120264 | KONAN SPECULAR MICROSCOPE XIV | Konan Medical, Inc. | 2012-04-11 | 72 | 0 |
| K081797 | IMAGE STORAGE SYSTEM, MODEL KSS-400 | Konan Medical, Inc. | 2009-01-22 | 211 | 0 |
| K062763 | NONCON ROBO PACHY F&A | Konan Medical, Inc. | 2008-02-22 | 525 | 0 |
| K040373 | KERATO ANALYZER (EKA) | Konan Medical, Inc. | 2004-03-19 | 31 | 0 |
| K950091 | KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP | Konan Medical, Inc. | 1995-03-01 | 50 | 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