Data / Medical devices / United States / Reichert Inc.
Reichert Inc.: FDA-registered device maker in Depew, NY, United States, 16 510(k) clearances
Reichert Inc. is registered with the FDA (registration 1319721) in Depew, NY, United States. It lists 19 device types. The FDA files 16 510(k) clearances under its listings, the newest dated May 1, 2024. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1319721
- FEI number
- 1000159913
- Address
- 3362 Walden Ave Suite 100, Depew, NY, United States, 14043
- Owner or operator
- REICHERT INC. (9055850)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- May 9, 1995
- Registered through
- 2027
- Brand names listed
- ACTIVA MED, CATS Tonometer Prism, CP-D Circular Polarizer, CT210 Contact Tonometer, ClearChart® 4, ClearChart® 4P, ClearChart® 4X, DEM 100 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Colony Counter | KZB | 1 | Manufacturer | accessdata.fda.gov |
| Bilirubin (Total And Unbound) In The Neonate Test System | MQM | 1 | Manufacturer | accessdata.fda.gov |
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Camera, Ophthalmic, Ac-Powered | HKI | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Chart, Visual Acuity | HOX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Frame, Trial, Ophthalmic | HPA | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Measuring, Lens, Ac-Powered | HLM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Light, Examination, Medical, Battery Powered | KYT | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Manual Colony Counter | KZC | 1 | Manufacturer | accessdata.fda.gov |
| Pad, Heating, Powered | IRT | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Pupillometer, Manual | HLH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Refractometer For Clinical Use | JRE | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Refractometer For Donor Testing | PSM | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Refractor, Manual, Non-Powered, Including Phoropter | HKN | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Set, Lens, Trial, Ophthalmic | HPC | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Tonometer, Ac-Powered | HKX | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tonometer, Manual | HKY | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Topographer, Corneal, Ac-Powered | MMQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 1, 2024 | K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) | HKY | Substantially Equivalent | Reichert, Inc. | accessdata.fda.gov |
| March 9, 2018 | K173904 | CATS Tonometer Prism | HKY | Substantially Equivalent | Cats Tonometer, LLC | accessdata.fda.gov |
| October 6, 2017 | K170470 | Digital Eye Anterior Camera | HJO | Substantially Equivalent | Medimaging Integrated Solution, Inc (Miis) | accessdata.fda.gov |
| October 15, 2014 | K141954 | XCEL 455 SLIT LAMP | HJO | Substantially Equivalent | Reichert, Inc. | accessdata.fda.gov |
| August 7, 2008 | K081756 | OCULAR RESPONSE ANALYZER | HKX | Substantially Equivalent | Reichert, Inc. | accessdata.fda.gov |
| March 27, 2007 | K070534 | MODIFICATION TO: OCU-FILM TIP COVER | HKY | Substantially Equivalent | Reichert, Inc. | accessdata.fda.gov |
| December 20, 2006 | K063750 | XCEL 255 SLIT LAMP | HJO | Substantially Equivalent | Reichert, Inc. | accessdata.fda.gov |
| May 25, 2006 | K061330 | PSL PORTABLE SLIT LAMP | HJO | Substantially Equivalent | Reichert, Inc. | accessdata.fda.gov |
| March 3, 2006 | K053430 | TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER | HKY | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| January 20, 2004 | K032799 | NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER | HKX | Substantially Equivalent | Reichert, Inc. | accessdata.fda.gov |
| March 21, 2003 | K030610 | POD PAC-20M | IYO | Substantially Equivalent | Portable Ophthalmic Devices, Inc. | accessdata.fda.gov |
| December 11, 2000 | K002395 | MODEL 30 CLASSIC PNEUMATONOMETER | HKX | Substantially Equivalent | Xomed, Inc. | accessdata.fda.gov |
| March 23, 2000 | K000288 | REICHERT CT200 CONTACT TONOMETER | HKY | Substantially Equivalent | Reichert Ophthalmic Instruments, Div. Leica, Inc. | accessdata.fda.gov |
| June 7, 1999 | K990869 | LEICA AT550 | HKX | Substantially Equivalent | Leica Microsystems, Inc. | accessdata.fda.gov |
| June 22, 1993 | K921443 | TIP & MEMBRANE ASSEMBLY | HKX | Substantially Equivalent | Bio-Rad | accessdata.fda.gov |
| August 18, 1992 | K922770 | UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311 | MQM | Substantially Equivalent | Leica, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 28, 2025 | 96266 | Class II | Ongoing | 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. | accessdata.fda.gov |
| July 20, 2023 | 92805 | Class II | Ongoing | 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 | 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 | accessdata.fda.gov |
Compare with other makers
- All makers of Tonometer, Manual
- All makers of Biomicroscope, Slit-Lamp, Ac-Powered
- All makers of Tonometer, Ac-Powered
- All makers of Chart, Visual Acuity
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Frame, Trial, Ophthalmic
Updated March 31, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.