Cleared Traditional

K885230 - MCDONALD FOLDING FORCEPS

K885230 is an FDA 510(k) clearance for MCDONALD FOLDING FORCEPS, manufactured by Alcon Laboratories. The device is a Class 1 Ophthalmic device with product code HNR cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K885230 · Alcon Laboratories · Ophthalmic device
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May 1989
Decision
148d
Days
Class 1
Risk

K885230 is an FDA 510(k) clearance for the MCDONALD FOLDING FORCEPS. Classified as Forceps, Ophthalmic (product code HNR), Class I - General Controls.

Submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on May 17, 1989 after a review of 148 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 Alcon Laboratories devices

FDA 510(k) Submission Details - K885230

510(k) Number K885230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1988
Decision Date May 17, 1989
Days to Decision 148 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
38d slower than avg
Panel avg: 110d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

HNR Device Classification - Class 1, General Controls

Product Code HNR Forceps, 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 - HNR Forceps, Ophthalmic

All 32
Devices cleared under the same product code (HNR) and FDA review panel - the closest regulatory comparables to K885230.
ALCON FOLDING FORCEPS
K895434 · Alcon Laboratories · Dec 1989
ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS
K880274 · Advanced Surgical Products, Inc. · Feb 1988
FAULKNER FORCEPS
K864071 · Staar Surgical Co. · Nov 1986
THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND
K863991 · Keeler Instruments, Inc. · Oct 1986
THORNTON TITANIUM FORCEPS (VARIOUS TYPES)
K863992 · Keeler Instruments, Inc. · Oct 1986
PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS
K864003 · Allergan, Inc. · Oct 1986