Diopsys Inc

Middletown, PA, US

DIOPSYS INC. appears in FDA device records in Middletown, PA. FDA records list 2 510(k) clearances between 2005-03-16 and 2011-05-09, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 2
Registered establishments: 1

510(k) clearance history

FDA records hold 2 510(k) clearances for Diopsys Inc between 2005 and 2011. The busiest year on record is 2005, with 1. The most recent is 2011, with 1.

Clearances by year, as a table

510(k) clearance decisions for Diopsys Inc, by decision year
Year	Clearances
2005	1
2011	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K101763	DIOPSYS NOVA VEP VISION TESTING SYSTEM	GWE	Substantially Equivalent	2011-05-09
K043491	ENFANTTM	GWE	Substantially Equivalent	2005-03-16

Registered establishments

FDA registered establishments for Diopsys Inc, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3004174467	3004174467	DIOPSYS INC.	1000 Kreider Drive, Middletown, PA 17057 US	2026	GWE

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

GWEStimulator, Photic, Evoked Response

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1437-2010	Diopsys Inc., Enfant Pediatric VEP Vision Testing System, Input: 120 Vac, 60Hz/2.5A IEC 60601-1 Class I, Type BF.	The computer based system may lose test counts when the time in the device was changed during a changeover from standard time to daylight savings time in March 2007.		2007-04-02	Terminated
Z-0186-05	The Enfant Evoked Response Photic Stimulator. The Enfant A Pediatric Vision Testing Device, Manufactured by Diopsys, Inc., 355 Main St., Metuchen, NJ 08840. Each medical device unit is assembled and contains an 18 inch flat panel vision stimulator panel, a 17 inch flat panel operator monitor, a 2.25 inch thermal printer, a mobile point of care cart, medical grade battery back-up, speaker, a CPU with floppy and CD drives, a camera and an isolation transformer.	The firm established no medical device quality system, no established quality plan and no established quality procedures.		2004-09-15	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain