Data / Medical devices / United States / Accutome, Inc.
Accutome, Inc.: FDA-registered device maker in Malvern, PA, United States, 37 510(k) clearances
Accutome, Inc. is registered with the FDA (registration 2521877) in Malvern, PA, United States. It lists 48 device types. The FDA files 37 510(k) clearances under its listings, the newest dated February 8, 2019. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2521877
- Address
- 3222 Phoenixville Pike, Malvern, PA, United States, 19355
- Owner or operator
- ACCUTOME, INC. (2521877)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- July 29, 1992
- Registered through
- 2027
- Brand names listed
- DIAMOND OPHTHLMIC KNIFE, GENERIC, Generic, IMMERSION SHELL, OPHTHALMIC MARKER, OPHTHALMIC RING, OPHTHAMIC CURETTE, Punch, Kelly and more
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 |
|---|---|---|---|---|---|---|
| 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 |
| December 31, 2015 | K152644 | KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 | HKY | Substantially Equivalent | Keeler Limited | accessdata.fda.gov |
| November 25, 2015 | K152573 | 4Sight | IYO | Substantially Equivalent | Accutome, Inc. | accessdata.fda.gov |
| September 17, 2014 | K142179 | D-KAT Z-YPE | HKY | Substantially Equivalent | Keeler, Ltd. | accessdata.fda.gov |
| July 11, 2014 | K140451 | KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION) | HJO | Substantially Equivalent | Keeler Limited | accessdata.fda.gov |
| June 17, 2014 | K140450 | KEELER KAPTURE SOFTWARE | HKI | Substantially Equivalent | Keeler Limited | accessdata.fda.gov |
| April 23, 2014 | K132549 | ACCUTIP COVER | HKY | Substantially Equivalent | Accutome, Inc. | 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 |
| January 29, 2013 | K123349 | A-SCAN PLUS CONNECT | IYO | Substantially Equivalent | Accutome, Inc. | accessdata.fda.gov |
| March 14, 2011 | K103471 | UBM PLUS | IYN | Substantially Equivalent | Accutome, Inc. | 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 |
| July 27, 2009 | K083377 | ACCUPEN | HKX | Substantially Equivalent | Accutome Ultrasound, Inc. | accessdata.fda.gov |
| April 19, 2007 | K070943 | B-SCAN PLUS | IYO | Substantially Equivalent | Accutome Ultrasound, Inc. | 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 |
| May 19, 2006 | K053638 | MANI NEEDLE & SUTURE PACK (SILK) | GAP | Substantially Equivalent | Mani, Inc. | accessdata.fda.gov |
| May 19, 2006 | K053637 | MANI NEEDLE & SUTURE PACK (NYLON) | GAR | Substantially Equivalent | Mani, Inc. | accessdata.fda.gov |
| March 14, 2006 | K053636 | MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) | GAM | Substantially Equivalent | Mani, Inc. | accessdata.fda.gov |
| December 5, 2005 | K050150 | MANI NEEDLE & SUTURE PACK | GAT | Substantially Equivalent | Mani, Inc. | accessdata.fda.gov |
| March 28, 2005 | K050552 | PACHPEN PACHYMETER, MODEL 24-5100 | IYO | Substantially Equivalent | Accutome, Inc. | accessdata.fda.gov |
| November 10, 2004 | K042752 | ACCUPACH V | IYO | Substantially Equivalent | Accutome Ultrasound, Inc. | accessdata.fda.gov |
| March 26, 2004 | K023525 | RETISCAN, RETIPORT | GWE | Substantially Equivalent | Roland Consult | accessdata.fda.gov |
| November 26, 2003 | K032087 | KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 | HLJ | Substantially Equivalent | Keeler Instruments, Inc. | accessdata.fda.gov |
| March 25, 1999 | K990257 | KEELER PULSAIR 3000 NON CONTACT TONOMETER | HKX | 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 |
| 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 |
| February 12, 1987 | K870203 | KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5 | HKK | 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 February 8, 2019. 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.