510(k) Report

FDA applicant

Parker Laboratories, Inc.

Mchenry, IL30 decisions1977–20245 recalls

FDA records 30 decisions for Parker Laboratories, Inc. (Mchenry, IL) from 1977 to 2024: 30 510(k) clearances. Most are in product codes GYB (Media, Electroconductive) and IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 1 predicate, 0 of them its own earlier devices. 5 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Parker Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

3in 2024

2014: 12017: 12024: 3
2007high 3 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Parker Laboratories, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Parker Laboratories, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GYBMedia, Electroconductive4decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic3decisions
  • EMACement, Dental2decisions
  • EBIResin, Denture, Relining, Repairing, Rebasing2decisions
  • ITXTransducer, Ultrasonic, Diagnostic2decisions
  • EAQDetector, Ultraviolet1decision

Also: EGG (1), FAX (1), EGJ (1), EBG (1), EFN (1), EFH (1).

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K802146Aquasonic 100 Ultrasound Trans. Gel,Parker Laboratories, Inc. · 19803cite it
  • K782055Cream, SignaParker Laboratories, Inc. · 19791cites it
  • K851895Polygel Ultrasound GelParker Laboratories, Inc. · 19851cites it
  • K852956Contact Conductive Adhesive Gel CompositionParker Laboratories, Inc. · 19851cites it
  • K953673Eclipse Probe CoverParker Laboratories, Inc. · 19961cites it

What has FDA decided for it lately?

  • K233965UltraDrape UGPIV Barrier and Securement (34-15)Parker Laboratories, Inc. · 2024
  • K953673Eclipse Probe CoverParker Laboratories, Inc. · 19961 recall
  • K921695Ultra Cover Ultrasound Transducer Probe CoversParker Laboratories, Inc. · 1995
  • K864556Aqualube (TM)Parker Laboratories, Inc. · 1986
  • K861239Acrylic SolderParker Laboratories, Inc. · 1986
  • K855167Dyna SystemParker Laboratories, Inc. · 1986
  • K851895Polygel Ultrasound GelParker Laboratories, Inc. · 1985
  • K852956Contact Conductive Adhesive Gel CompositionParker Laboratories, Inc. · 19853 recalls

All 30 as Parker Laboratories, Inc. →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K852956TENSIVE Conductive Adhesive Gel, REF 016-401600Feb 7, 2024Class II
  • K852956natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series…Feb 7, 2024Class II
  • K852956Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes…Jan 22, 2024Class II
  • K802146Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400…Apr 13, 2017Class II
  • K953673Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size…Aug 6, 2014Class II

Other applicant names beginning “Parker”

FDA records each applicant name separately; these may or may not be the same firm.

Parker Hannifin Corp. 14Parker Treadmill Co., Inc. 2Parker Medical Assoc. 1