Cleared Traditional

K032087 - KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004

K032087 is an FDA 510(k) clearance for KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL ..., manufactured by Keeler Instruments, Inc.. The device is a Class 2 Ophthalmic device with product code HLJ cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K032087 · Keeler Instruments, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
142d
Days
Class 2
Risk

K032087 is an FDA 510(k) clearance for the KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004. Classified as Ophthalmoscope, Battery-powered (product code HLJ), Class II - Special Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on November 26, 2003 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - 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.

FDA 510(k) Submission Details - K032087

510(k) Number K032087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2003
Decision Date November 26, 2003
Days to Decision 142 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 110d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLJ Device Classification - Class 2, Special Controls

Product Code HLJ Ophthalmoscope, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HLJ Ophthalmoscope, Battery-powered

All 40
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K032087 · KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
Download PDF FDA Summary Keeler Instruments, I…