Reichert, Inc.
Depew, NY, US
REICHERT INC. appears in FDA device records in Depew, NY. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Reichert, Inc. between 2004 and 2024. The busiest year on record is 2004, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 2 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 2 |
| 2014 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) | HKY | Substantially Equivalent | |
| K141954 | XCEL 455 SLIT LAMP | HJO | Substantially Equivalent | |
| K081756 | OCULAR RESPONSE ANALYZER | HKX | Substantially Equivalent | |
| K071839 | SOCT COPERNICUS, MODEL 15205 | OBO | Substantially Equivalent | |
| K070534 | MODIFICATION TO: OCU-FILM TIP COVER | HKY | Substantially Equivalent | |
| K063750 | XCEL 255 SLIT LAMP | HJO | Substantially Equivalent | |
| K061330 | PSL PORTABLE SLIT LAMP | HJO | Substantially Equivalent | |
| K042831 | ATP (AUTO NON-CONTACT TONOMETER/PACHYMETER) | IYO | Substantially Equivalent | |
| K032799 | NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER | HKX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1319721 | 1000159913 | REICHERT INC. | 3362 Walden Ave, DEPEW, NY 14043 US | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KZBAutomated Colony Counter
- MQMBilirubin (Total And Unbound) In The Neonate Test System
- HJOBiomicroscope, Slit-Lamp, Ac-Powered
- HKICamera, Ophthalmic, Ac-Powered
- HOXChart, Visual Acuity
- HPAFrame, Trial, Ophthalmic
- HLMInstrument, Measuring, Lens, Ac-Powered
- KYTLight, Examination, Medical, Battery Powered
- KZCManual Colony Counter
- IRTPad, Heating, Powered
- HLHPupillometer, Manual
- JRERefractometer For Clinical Use
- PSMRefractometer For Donor Testing
- HKORefractometer, Ophthalmic
- HKNRefractor, Manual, Non-Powered, Including Phoropter
- HPCSet, Lens, Trial, Ophthalmic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- OBOTomography, Optical Coherence
- HKXTonometer, Ac-Powered
- HKYTonometer, Manual
- MMQTopographer, Corneal, Ac-Powered
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1501-2025 | Phoroptor VRx Digital Refraction System Model Numbers: 16242 | The head of the phoropter head could come loose and potentially detach due to a default in the assembly. | Class II | Open, Classified | |
| Z-1500-2025 | Phoroptor VRx Digital Refraction System Model Numbers: 16241 | The head of the phoropter head could come loose and potentially detach due to a default in the assembly. | Class II | Open, Classified | |
| Z-2512-2023 | PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye. MODEL NUMBER: 16242 [Model 16241 is the base model. Model 16242 includes an additional prism feature used for the measurement of ocular deviation in patients with latent or manifest strabismus]. | Phoroptor VRx Head may detach from the bracket that connects the Phoroptor VRx Head to an ophthalmic stand. If the Phoroptor VRx Head detaches from the bracket, it can fall onto a patient or device operator | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain