Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
NQE — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
267 daysmedian FDA review time
525 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191558 | Konan Specular Microscope XVII | Konan Medical, Inc. | 2020-03-26 | 288 | 0 |
| K173980 | Specular Microscope CEM-530 | Nidek Co., Ltd. | 2018-03-14 | 75 | 0 |
| K171313 | EM-4000 Specular Microscope | Tomey Corporation | 2018-01-19 | 260 | 0 |
| K151706 | Specular Microscope CEM- 530 | Nidek Co., Ltd. | 2016-03-17 | 267 | 1 |
| K142417 | SP-1PSpecular Microscope | Topcon Corporation | 2015-05-29 | 274 | 0 |
| K130565 | SPECULAR MICROSCOPE CEM-530 | Nidek Co., Ltd. | 2013-11-27 | 268 | 0 |
| K120264 | KONAN SPECULAR MICROSCOPE XIV | Konan Medical, Inc. | 2012-04-11 | 72 | 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 |
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