Cleared Traditional

K841807 - OPERAID NUCLEUS

K841807 is the FDA 510(k) clearance for OPERAID NUCLEUS by Jedmed Instrument Co.. It is a Class 1 Ophthalmic device (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

Submission Details

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.

Device Classification

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 10
Devices cleared under the same product code (KYG) and FDA review panel - the closest regulatory comparables to K841807.
ALCON SITE(R)-COMPATIBLE CASSETTE
K881682 · Alcon Laboratories · Jul 1988
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