Reichert, Inc.: FDA clearances and approvals
Reichert, Inc. has 9 FDA 510(k) clearances (first 2004, latest 2024), across 5 product codes in 2 review panels. Median 510(k) review time: 48 days. openFDA lists 3 product recalls by a recalling firm named Reichert, Inc. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 89 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 182 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Reichert, Inc.'s cleared 510(k)s took a median 182 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 142 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 3 | 3 |
| HKX | Tonometer, Ac-Powered | 2 | 2 |
| HKY | Tonometer, Manual | 2 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 | 1 |
| OBO | Tomography, Optical Coherence | 1 | 1 |
Review panels
- Ophthalmic (8)
- Radiology (1)
Most recent Reichert, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) | HKY | 2024-05-01 | 182 |
| K141954 | XCEL 455 SLIT LAMP | HJO | 2014-10-15 | 89 |
| K081756 | OCULAR RESPONSE ANALYZER | HKX | 2008-08-07 | 48 |
| K071839 | SOCT COPERNICUS, MODEL 15205 | OBO | 2008-02-27 | 237 |
| K070534 | MODIFICATION TO: OCU-FILM TIP COVER | HKY | 2007-03-27 | 29 |
| K063750 | XCEL 255 SLIT LAMP | HJO | 2006-12-20 | 1 |
| K061330 | PSL PORTABLE SLIT LAMP | HJO | 2006-05-25 | 13 |
| K042831 | ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER) | IYO | 2004-10-28 | 15 |
| K032799 | NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER | HKX | 2004-01-20 | 133 |
Recalls
3 product recalls in 2 recall events; 3 initiated in the last five years. Most recent: 2025-02-28.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Reichert, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04360369: Comparison of Intraocular Pressure Measurements Between Reichert Tono-Vera Tonometer and Goldmann Tonometry (Completed, started 2020-10-19)
Frequently asked questions
How many FDA 510(k) clearances does Reichert, Inc. have?
Reichert, Inc. has 9 FDA 510(k) clearances (first 2004, latest 2024), across 5 product codes in 2 review panels.
How long does FDA take to clear Reichert, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Reichert, Inc.'s cleared 510(k)s is 48 days.
What devices does Reichert, Inc. make?
Its most frequent FDA product codes are HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 3); HKX (Tonometer, Ac-Powered, 2); HKY (Tonometer, Manual, 2).
Has Reichert, Inc. had device recalls?
openFDA lists 3 product recalls in 2 recall events by a recalling firm whose name matches Reichert, Inc; the most recent began 2025-02-28. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 9 Reichert, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HJO, Reichert, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.