510(k) Report

FDA applicant

Chester Labs, Inc.

Cincinnati, OH11 decisions1985–20041 recall

FDA records 11 decisions for Chester Labs, Inc. (Cincinnati, OH) from 1985 to 2004: 11 510(k) clearances. Most are in product codes GYB (Media, Electroconductive) and LYY (Latex Patient Examination Glove). 1 recall is linked to its devices.

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

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

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

FDA decisions per year

No FDA decision for Chester Labs, Inc. since 2007.

Recalls per year

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • GYBMedia, Electroconductive5decisions
  • LYYLatex Patient Examination Glove2decisions
  • IYOSystem, Imaging, Pulsed Echo, Ultrasonic1decision
  • IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat1decision
  • KMJLubricant, Patient1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K041060E-Z Lubricating JellyChester Labs, Inc. · 20042cite it
  • K841871Liqua-Sonic GelChester Labs, Inc. · 19851cites it

What has FDA decided for it lately?

  • K041060E-Z Lubricating JellyChester Labs, Inc. · 20041 recall
  • K001705Statsign Electrode Conductivity Gel, Graham-Field Electrode Conductivity Gel, Models 004008, 48-4000 2GF…Chester Labs, Inc. · 2000
  • K001593Modification to Statsign Saline Electrolyte Gel, Graham-Field Saline Electrolyte GelChester Labs, Inc. · 2000
  • K944598Graham-Field Electrode Conductivity GelChester Labs, Inc. · 1996
  • K944599Graham-Field Conductive Ecg SprayChester Labs, Inc. · 1996
  • K944600Graham-Field Saline Electrolyte GelChester Labs, Inc. · 1995
  • K944597Graham-Field Ultrasound Scanning GelChester Labs, Inc. · 1995
  • K944596Graham-Field Ultrasound LotionChester Labs, Inc. · 1995

All 11 as Chester Labs, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K041060Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml).…Dec 12, 2016Class II