Data / Medical devices / United States / Parker Laboratories, Inc.
Parker Laboratories, Inc.: FDA-registered device maker in Fairfield, NJ, United States, 8 510(k) clearances
Parker Laboratories, Inc. is registered with the FDA (registration 2212018) in Fairfield, NJ, United States. It lists 9 device types. The FDA files 8 510(k) clearances under its listings, the newest dated March 14, 1996. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2212018
- Address
- 286 Eldridge RD., Fairfield, NJ, United States, 07004
- Owner or operator
- PARKER LABORATORIES, INC. (2212018)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- February 6, 2008
- Registered through
- 2027
- Brand names listed
- Alpha-Stim Conductive Solution, Aquaflex, Aquagel Lubricating Gel, Aquasonic 100, Aquasonic 100 Sterile, Aquasonic Clear, Brainscope Skin Prep Gel, Delphinus Sequr Breast Interface and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Electrosurgical | HAM | 2 | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Contract manufacturer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Contract manufacturer | accessdata.fda.gov |
| Foam Or Gel Chemical Sterilant/High Level Disinfectant | QWS | 2 | Contract manufacturer | accessdata.fda.gov |
| Lubricant, Patient | KMJ | 1 | Manufacturer | accessdata.fda.gov |
| Media, Coupling, Ultrasound | MUI | 2 | Manufacturer | accessdata.fda.gov |
| Media, Electroconductive | GYB | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 14, 1996 | K953673 | ECLIPSE PROBE COVER | IYO | Substantially Equivalent | Parker Laboratories, Inc. | accessdata.fda.gov |
| December 1, 1986 | K864556 | AQUALUBE(TM) | KMJ | Substantially Equivalent | Parker Laboratories, Inc. | accessdata.fda.gov |
| September 27, 1985 | K851895 | POLYGEL ULTRASOUND GEL | IYO | Substantially Equivalent | Parker Laboratories, Inc. | accessdata.fda.gov |
| August 9, 1985 | K852956 | CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION | GYB | Substantially Equivalent | Parker Laboratories, Inc. | accessdata.fda.gov |
| April 16, 1982 | K827296 | POLYSONIC ULTRASOUND LOTION | MUI | Substantially Equivalent | Parker Laboratories, Inc. | accessdata.fda.gov |
| October 10, 1980 | K802146 | AQUASONIC 100 ULTRASOUND TRANS. GEL, | IYO | Substantially Equivalent | Parker Laboratories, Inc. | accessdata.fda.gov |
| March 21, 1979 | K782055 | CREAM, SIGNA | GYB | Substantially Equivalent | Parker Laboratories, Inc. | accessdata.fda.gov |
| July 27, 1978 | K780973 | SIGNAPAD | GYB | Substantially Equivalent | Parker Laboratories, 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 |
|---|---|---|---|---|---|---|
| March 22, 2024 | 94303 | Class II | Ongoing | Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme. | Product demonstrates low viscosity. | accessdata.fda.gov |
| January 22, 2024 | 93891 | Class II | Ongoing | 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. | accessdata.fda.gov |
| April 13, 2017 | 79910 | Class II | Terminated | 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. | accessdata.fda.gov |
| August 6, 2014 | 69224 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Media, Coupling, Ultrasound
- All makers of Media, Electroconductive
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Lubricant, Patient
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Updated April 19, 2024. 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.