Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MYC — Predicate Candidate Screening
22 FDA 510(k) clearances under this product code; the 50 most recent screened below.
116 daysmedian FDA review time
295 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241931 | OcuMet Beacon (OCUB100) | Ocusciences, Inc. | 2025-04-22 | 295 | 0 |
| K243504 | MAIA (AHMACME001) | Centervue S.P.A. | 2025-03-17 | 125 | 0 |
| K213705 | DRSplus | Centervue S.P.A. | 2021-12-21 | 27 | 0 |
| K211328 | EIDON FA, EIDON, EIDON AF, EIDON UWFL | Centervue S.P.A. | 2021-08-19 | 108 | 0 |
| K192113 | DRSplus | Centervue S.P.A. | 2019-11-15 | 102 | 0 |
| K180526 | EIDON FA | Centervue S.P.A. | 2018-07-16 | 139 | 0 |
| K180293 | Retia 2 | Centervue S.P.A. | 2018-05-30 | 118 | 0 |
| K153181 | MAIA | Centervue S.P.A. | 2016-06-08 | 218 | 0 |
| K150320 | COMPASS | Centervue S.P.A. | 2015-06-30 | 141 | 0 |
| K142897 | P200DTx | Optos Plc. | 2015-01-16 | 105 | 0 |
| K142047 | EIDON | Centervue S.P.A. | 2014-11-12 | 107 | 0 |
| K134039 | DAYTONA ICG (P200TICG) | Optos Plc. | 2014-04-11 | 101 | 0 |
| K112880 | CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE | Freedom Meditech, Inc. | 2013-01-31 | 489 | 0 |
| K111988 | EASYSCAN MODEL 1.2 | I-Optics BV | 2011-10-28 | 107 | 0 |
| K111628 | P200T | Optos Plc. | 2011-08-19 | 70 | 0 |
| K102492 | P200MAAF | Optos Plc. | 2010-09-30 | 30 | 0 |
| K100644 | OPTOS LIMITED PANORAMIC 200CAF | Optos Plc. | 2010-07-15 | 132 | 0 |
| K093521 | GDXPRO | Carl Zeiss Meditec, Inc. | 2009-11-25 | 12 | 0 |
| K082016 | GDX VCC WITH ECC SOFTWARE | Carl Zeiss Meditec, Inc. | 2009-08-10 | 391 | 0 |
| K091039 | KOWA, FM-600, MODEL LSS50 | Kowa Co. , Ltd. | 2009-08-07 | 116 | 0 |
| K072259 | OPHTHALMOSCOPE F-10 | Nidek Co., Ltd. | 2008-05-06 | 266 | 0 |
| K060424 | PANORAMIC, MODEL 200MA | Optos Plc. | 2006-03-17 | 28 | 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