Cleared Traditional

K954548 - THE CHEN MEDIUM

K954548 · Chen Ophthalmic Laboratories · Ophthalmic device

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May 1996

Decision

231d

Days

Risk

K954548 is an FDA 510(k) clearance for the THE CHEN MEDIUM. Classified as Media, Corneal Storage (product code LYX).

Submitted by Chen Ophthalmic Laboratories (Phoenix, US). The FDA issued a Cleared decision on May 20, 1996 after a review of 231 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel. 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 - K954548

510(k) Number	K954548 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 02, 1995
Decision Date	May 20, 1996
Days to Decision	231 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

121d slower than avg

Panel avg: 110d · This submission: 231d

Pathway characteristics

Predicate-based equivalence.

LYX Device Classification - Class 0,

Product Code	LYX Media, Corneal Storage
Device Class	-

Regulatory Peers - LYX Media, Corneal Storage

All 20

Devices cleared under the same product code (LYX) and FDA review panel - the closest regulatory comparables to K954548.

LIFE4C

K063304 · Numedis, Inc. · Dec 2007

EUSOL-C

K063617 · Al.Chi.Mi.A · Feb 2007

EUSOL-C

K032422 · Al.Chi.Mi.A · Dec 2003

OPTISOL-GS CORNEAL STORAGE MEDIA

K924165 · Chiron Intraoptics · Oct 1992

DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED

K921728 · Chiron Intraoptics · Jun 1992

OPTISOL CORNEAL STORAGE MEDIA CONTAINER/MODIFIED

K921729 · Chiron Intraoptics · Jun 1992

FDA 510(k) Resources - Ophthalmic

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K954548

Chen Ophthalmic Laboratories

Phoenix, MD · US

CHUNG-HO CHEN

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Ophthalmic

View all devices by Chen Ophthalmic Laboratories →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: May 20, 1996. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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