Parker Laboratories, Inc.

Fairfield, NJ, US

PARKER LABORATORIES, INC. appears in FDA device records in Fairfield, NJ. FDA records list 30 510(k) clearances between 1977-01-25 and 2024-08-15, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 4 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 30
PMA records: 0
Recall records: 4
Registered establishments: 1

510(k) clearance history

FDA records hold 30 510(k) clearances for Parker Laboratories, Inc. between 1977 and 2024. The busiest year on record is 1977, with 6. The most recent is 2024, with 1.

Clearances by year, as a table

510(k) clearance decisions for Parker Laboratories, Inc., by decision year
Year	Clearances
1977	6
1978	2
1979	4
1980	3
1981	1
1982	3
1983	1
1984	2
1985	2
1986	3
1995	1
1996	1
2024	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K233965	UltraDrape UGPIV Barrier and Securement (34-15)	ITX	Substantially Equivalent	2024-08-15
K953673	ECLIPSE PROBE COVER	IYO	Substantially Equivalent	1996-03-14
K921695	ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS	ITX	Substantially Equivalent	1995-02-23
K864556	AQUALUBE(TM)	KMJ	Substantially Equivalent	1986-12-01
K861239	ACRYLIC SOLDER	EBI	Substantially Equivalent	1986-04-17
K855167	DYNA SYSTEM	EGG	Substantially Equivalent	1986-03-04
K851895	POLYGEL ULTRASOUND GEL	IYO	Substantially Equivalent	1985-09-27
K852956	CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION	GYB	Substantially Equivalent	1985-08-09
K841400	NEURO PULSE	GZJ	Substantially Equivalent	1984-06-15
K840548	RESIL	EBI	Substantially Equivalent	1984-04-17
K831039	COMPLUS VARIOUS FORMS		Substantially Equivalent	1983-05-27
K822711	ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL	FAX	Substantially Equivalent	1982-11-03
K822896	CAVIDRY	EJH	Substantially Equivalent	1982-10-22
K827296	POLYSONIC ULTRASOUND LOTION	MUI	Substantially Equivalent	1982-04-16
K811995	FORAMATRON APICAL FORAMEN LOCATOR		Substantially Equivalent	1981-09-21
K802146	AQUASONIC 100 ULTRASOUND TRANS. GEL,	IYO	Substantially Equivalent	1980-10-10
K800060	PROVIT	EMA	Substantially Equivalent	1980-01-23
K790555	HEMO-WEDGE	DZN	Substantially Equivalent	1980-01-17
K792391	COTTON ROLL COMPRESSION CAPS	EFN	Substantially Equivalent	1979-12-06
K791013	SPECTRA R PAD	GYB	Substantially Equivalent	1979-09-17
K790638	ACCUTRON POLLUTION REDUCER	BSJ	Substantially Equivalent	1979-05-25
K782055	CREAM, SIGNA	GYB	Substantially Equivalent	1979-03-21
K781351	AURO-BRUSH		Substantially Equivalent	1978-12-04
K780973	SIGNAPAD	GYB	Substantially Equivalent	1978-07-27
K771527	ACCU. CROWN COLD CURE	EBG	Substantially Equivalent	1977-08-16
K771130	DESENSITRON	EGJ	Substantially Equivalent	1977-07-15
K771011	ARTICULATING PAPER	EFH	Substantially Equivalent	1977-06-20
K770685	LIGHT, EXAMINING, DENTAL, ULTRA VIOLET	EAQ	Substantially Equivalent	1977-04-26
K770684	CROWN, ACRYLIC, CORAL BRAND, PREFORMED	ELZ	Substantially Equivalent	1977-04-26
K770067	CYANOBOND	EMA	Substantially Equivalent	1977-01-25

Registered establishments

FDA registered establishments for Parker Laboratories, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2212018	2212018	PARKER LABORATORIES, INC.	286 ELDRIDGE RD., FAIRFIELD, NJ 07004 US	2026	GEI GYB HAM IYO KGX KMJ MUI NAE QWS

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

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1604-2024	Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.	Product demonstrates low viscosity.	Class II	2024-03-22	Open, Classified
Z-1204-2024	Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.	Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.	Class II	2024-01-22	Open, Classified
Z-1777-2018	Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case	There is a potential for the gel packets to have leaks in the packet seal.	Class II	2017-04-13	Terminated
Z-0145-2015	Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel Product Usage: For use as a protective cover for medical ultrasound probes/transducers.	Parker Laboratories, Inc. received a report of an incorrect expiration date on the inner boxes and on the plastic bags of the Eclipse Probe Covers.	Class II	2014-08-06	Terminated

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