Cleared Traditional

K830557 - ERG-JET ELECTRODE

K830557 is an FDA 510(k) clearance for ERG-JET ELECTRODE, manufactured by Universo S.A.. The device is a Class 2 Gastroenterology & Urology device with product code HLZ cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K830557 · Universo S.A. · Gastroenterology & Urology device
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Mar 1983
Decision
36d
Days
Class 2
Risk

K830557 is an FDA 510(k) clearance for the ERG-JET ELECTRODE. Classified as Electrode, Corneal (product code HLZ), Class II - Special Controls.

Submitted by Universo S.A. (Walker, US). The FDA issued a Cleared decision on March 31, 1983 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 886.1220 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K830557

510(k) Number K830557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1983
Decision Date March 31, 1983
Days to Decision 36 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 131d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLZ Device Classification - Class 2, Special Controls

Product Code HLZ Electrode, Corneal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1220
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - HLZ Electrode, Corneal

All 7
Devices cleared under the same product code (HLZ) and FDA review panel - the closest regulatory comparables to K830557.
RM Electrode (RMH 23-01)
K232273 · Retmap, Inc. · Dec 2023
TOMEY DTL ELECTRODE
K961805 · Tomey Corporation USA · May 1997
SOPHER AND BIERER OVUM FORCEPS
K926540 · Thomasville Medical Assoc. · Feb 1994
GOLD FOIL ERG ELECTRODES
K820254 · Cadwell Laboratories, Inc. · Apr 1982
ERG-JET ELECTRODE
K813399 · Nicolet Biomedical Instruments · Jan 1982
MULAR GOLD LEAF ELECTRODE MODEL 7501
K781476 · Life-Tech Instruments, Inc. · Nov 1978