Cleared Traditional

K980437 - SILICONE PUNCTAL PLUG

K980437 · Oasis Medical, Inc. · Ophthalmic device

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Apr 1998

Decision

85d

Days

Risk

K980437 is an FDA 510(k) clearance for the SILICONE PUNCTAL PLUG. Classified as Plug, Punctum (product code LZU).

Submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on April 30, 1998 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Oasis Medical, Inc. devices

FDA 510(k) Submission Details - K980437

510(k) Number	K980437 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 04, 1998
Decision Date	April 30, 1998
Days to Decision	85 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

25d faster than avg

Panel avg: 110d · This submission: 85d

Pathway characteristics

Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code	LZU Plug, Punctum
Device Class	-

Regulatory Peers - LZU Plug, Punctum

All 36

Devices cleared under the same product code (LZU) and FDA review panel - the closest regulatory comparables to K980437.

OPAQUE HERRICK PLUG, 0.3MM

K001737 · Lacrimedics, Inc. · Jun 2000

FLEXPLUG

K991130 · Eagle Vision, Inc. · Apr 1999

SURGIDEV SILICONE PUNCTUM PLUG

K980844 · Advanced Vision Science · May 1998

PUNCTUAL OCCLUDER

K972523 · Odyssey Medical, Inc. · Sep 1997

PUNCTUAL OCCLUDER

K970631 · Odyssey Medical, Inc. · Apr 1997

HERRICK ULTIMATE PUNCTUM PLUG

K963501 · Lacrimedics, Inc. · Apr 1997

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 K980437

Oasis Medical, Inc.

Glendora, CA · US

NORMAN DELGADO

Regulatory profile

17 submissions 17 cleared

100% clearance rate · Active in Ophthalmic

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: April 30, 1998. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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