Cleared Traditional

K830430 - EYELID SPECULUM

K830430 is an FDA 510(k) clearance for EYELID SPECULUM, manufactured by Douglas C. Mckee & Co.. The device is a Class 1 Ophthalmic device with product code HNC cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K830430 · Douglas C. Mckee & Co. · Ophthalmic device
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Jun 1983
Decision
121d
Days
Class 1
Risk

K830430 is an FDA 510(k) clearance for the EYELID SPECULUM. Classified as Specula, Ophthalmic (product code HNC), Class I - General Controls.

Submitted by Douglas C. Mckee & Co. (Mchenry, US). The FDA issued a Cleared decision on June 10, 1983 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4350 - 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 Douglas C. Mckee & Co. devices

FDA 510(k) Submission Details - K830430

510(k) Number K830430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1983
Decision Date June 10, 1983
Days to Decision 121 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 110d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

HNC Device Classification - Class 1, General Controls

Product Code HNC Specula, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4350
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 - HNC Specula, Ophthalmic

All 8
Devices cleared under the same product code (HNC) and FDA review panel - the closest regulatory comparables to K830430.
EYE FIXATION SPECULUM
K964289 · Eyefix, Inc. · Dec 1996
THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER)
K863989 · Keeler Instruments, Inc. · Oct 1986
VISITEC EYE SPECULUM
K843196 · Visitec Co. · Oct 1984
ASNIS GUIDED SCREW SYSTEMS
K801969 · Howmedica Corp. · Aug 1980
FELDSTEIN BLEPHAROPLASTY CLIP SHARP P
K760847 · V. Mueller O.V. Baxter Healthcare Corp. · Nov 1976
FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU
K760848 · V. Mueller O.V. Baxter Healthcare Corp. · Nov 1976