Cleared Traditional

K841807 - OPERAID NUCLEUS

K841807 is an FDA 510(k) clearance for OPERAID NUCLEUS, manufactured by Jedmed Instrument Co.. The device is a Class 1 Ophthalmic device with product code KYG cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K841807 · Jedmed Instrument Co. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
204d
Days
Class 1
Risk

K841807 is an FDA 510(k) clearance for the OPERAID NUCLEUS. Classified as Device, Irrigation, Ocular Surgery (product code KYG), Class I - General Controls.

Submitted by Jedmed Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on November 21, 1984 after a review of 204 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4360 - the FDA ophthalmic 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Jedmed Instrument Co. devices

FDA 510(k) Submission Details - K841807

510(k) Number K841807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1984
Decision Date November 21, 1984
Days to Decision 204 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 110d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

KYG Device Classification - Class 1, General Controls

Product Code KYG Device, Irrigation, Ocular Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4360
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KYG Device, Irrigation, Ocular Surgery

All 22
Devices cleared under the same product code (KYG) and FDA review panel - the closest regulatory comparables to K841807.
ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)
K861013 · Ameritek, Inc. · Mar 1986
VISITEC IRRIGATION CONTROL SYSTEM
K853243 · Visitec Co. · Sep 1985
OPERAID DISPOS. IRRIGATING KNIFE
K845039 · Jedmed Instrument Co. · Mar 1985
ELECATH HEPARIN COATED THERMAL DILUTION
K832787 · Electro-Catheter Corp. · Oct 1983
MICRO SURGICAL HANDLE
K831996 · Visitec Co. · Jul 1983