Cleared Traditional

K891487 - SOFT LENS FOLDING BLOCK

K891487 is the FDA 510(k) clearance for SOFT LENS FOLDING BLOCK by Western Medical Products, Inc.. It is a Class 1 Ophthalmic device (product code HNR) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K891487 · Western Medical Products, Inc. · Ophthalmic device
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Aug 1989
Decision
151d
Days
Class 1
Risk

K891487 is an FDA 510(k) clearance for the SOFT LENS FOLDING BLOCK. Classified as Forceps, Ophthalmic (product code HNR), Class I - General Controls.

Submitted by Western Medical Products, Inc. (San Diego, US). The FDA issued a Cleared decision on August 15, 1989 after a review of 151 days - an extended review cycle.

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 Western Medical Products, Inc. devices

Submission Details

510(k) Number K891487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1989
Decision Date August 15, 1989
Days to Decision 151 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 110d · This submission: 151d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 29
Devices cleared under the same product code (HNR) and FDA review panel - the closest regulatory comparables to K891487.
ALCON FOLDING FORCEPS
K895434 · Alcon Laboratories · Dec 1989
MCDONALD FOLDING FORCEPS
K885230 · Alcon Laboratories · May 1989
ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS
K880274 · Advanced Surgical Products, Inc. · Feb 1988
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