Cleared Traditional

K980437 - SILICONE PUNCTAL PLUG (FDA 510(k) Clearance)

K980437 · Oasis Medical, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 110d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZU Plug, Punctum
Device Class -