Data / Medical devices / United Kingdom / Keeler Ltd.
Keeler Ltd.: FDA-registered device maker in WINDSOR, BERKSHIRE Windsor and Maidenhead, United Kingdom, 22 510(k) clearances
Keeler Ltd. is registered with the FDA (registration 1000391004) in WINDSOR, BERKSHIRE Windsor and Maidenhead, United Kingdom. It lists 21 device types. The FDA files 22 510(k) clearances under its listings, the newest dated July 11, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1000391004
- Address
- Clewer Hill RD., WINDSOR, BERKSHIRE Windsor and Maidenhead, United Kingdom, SL4 4AA
- Owner or operator
- KEELER LTD. (9011500)
- Roles
- Contract manufacturer, Manufacturer, Specification developer
- First device listed
- November 9, 2005
- Registered through
- 2027
Devices it lists
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 |
|---|---|---|---|---|---|---|
| July 11, 2025 | K243227 | B-Scan | IYO | Substantially Equivalent | Accutome, Inc. Doing Business AS Keeler USA | accessdata.fda.gov |
| February 8, 2019 | K181143 | Keeler TonoCare Tonometer | HKX | Substantially Equivalent | Keeler Instruments, Inc. | accessdata.fda.gov |
| February 28, 2017 | K162837 | Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532 Laser System | GEX | Substantially Equivalent | Lumenis, Ltd. | accessdata.fda.gov |
| September 10, 2015 | K151394 | Keeler Slit Lamp | HJO | Substantially Equivalent | Keeler Limited | accessdata.fda.gov |
| September 17, 2014 | K142179 | D-KAT Z-YPE | HKY | Substantially Equivalent | Keeler, Ltd. | accessdata.fda.gov |
| June 17, 2014 | K140450 | KEELER KAPTURE SOFTWARE | HKI | Substantially Equivalent | Keeler Limited | accessdata.fda.gov |
| February 21, 2014 | K133234 | T-TYPE D-KAT, R-TYPE D-KAT | HKY | Substantially Equivalent | Keeler Limited | accessdata.fda.gov |
| December 23, 2013 | K131787 | CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES | HRN | Substantially Equivalent | Keeler, Ltd. | accessdata.fda.gov |
| June 27, 2013 | K131589 | KEELER SLIT LAMP H-SERIES | HJO | Substantially Equivalent | Keeler, Ltd. | accessdata.fda.gov |
| December 10, 2010 | K093298 | PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 | HKX | Substantially Equivalent | Keeler Instruments, Inc. | accessdata.fda.gov |
| March 9, 2010 | K100500 | PSL CLASSIC SLIT LAMP | HJO | Substantially Equivalent | Keeler Instruments, Inc. | accessdata.fda.gov |
| January 19, 2010 | K093445 | KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) | HKY | Substantially Equivalent | Keeler, Ltd. | accessdata.fda.gov |
| November 6, 2006 | K062412 | CRYOMATIC | HRN | Substantially Equivalent | Keeler Instruments, Inc. | accessdata.fda.gov |
| May 23, 2006 | K060822 | VANTAGE INDIRECT OPHTHALMOSCOPE | HLI | Substantially Equivalent | Keeler Instruments, Inc. | accessdata.fda.gov |
| April 2, 1997 | K970029 | KEELER SPECTRA INDIRECT OPHTHALMOSCOPE | HLJ | Substantially Equivalent | Keeler Instruments, Inc. | accessdata.fda.gov |
| November 22, 1994 | K942180 | KEELER MULTILASE 3000 | HQF | Substantially Equivalent | Keeler Instruments, Inc. | accessdata.fda.gov |
| August 4, 1994 | K942104 | KEELER VANTAGE INDIRECT OPHTHALMOSCOPE | HLI | Substantially Equivalent | Keeler Instruments, Inc. | accessdata.fda.gov |
| September 21, 1989 | K893171 | VISTA STREAK RETINOSCOPE (AC-POWERED) | HKL | Substantially Equivalent | Keeler Instruments, Inc. | accessdata.fda.gov |
| June 5, 1989 | K893173 | VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC) | HLI | Substantially Equivalent | Keeler Instruments, Inc. | accessdata.fda.gov |
| June 5, 1989 | K893172 | VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED) | HLI | Substantially Equivalent | Keeler Instruments, Inc. | accessdata.fda.gov |
| June 5, 1989 | K893170 | VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) | HJM | Substantially Equivalent | Keeler Instruments, Inc. | accessdata.fda.gov |
| November 12, 1985 | K854244 | THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE | HLI | Substantially Equivalent | Keeler Instruments, Inc. | accessdata.fda.gov |
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Updated July 11, 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.