Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Reichert, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
237 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 1 | Reichert, Inc. | 2024-05-01 | 182 | 0 |
| K141954 | XCEL 455 SLIT LAMP | Reichert, Inc. | 2014-10-15 | 89 | 0 |
| K081756 | OCULAR RESPONSE ANALYZER | Reichert, Inc. | 2008-08-07 | 48 | 0 |
| K071839 | SOCT COPERNICUS, MODEL 15205 | Reichert, Inc. | 2008-02-27 | 237 | 0 |
| K070534 | MODIFICATION TO: OCU-FILM TIP COVER | Reichert, Inc. | 2007-03-27 | 29 | 0 |
| K063750 | XCEL 255 SLIT LAMP | Reichert, Inc. | 2006-12-20 | 1 | 0 |
| K061330 | PSL PORTABLE SLIT LAMP | Reichert, Inc. | 2006-05-25 | 13 | 0 |
| K042831 | ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER) | Reichert, Inc. | 2004-10-28 | 15 | 0 |
| K032799 | NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER | Reichert, Inc. | 2004-01-20 | 133 | 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