Cleared Traditional

K090938 - FLOW CONTROLLER

K090938 · Odyssey Medical, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
62d
Days
-
Risk

K090938 is an FDA 510(k) clearance for the FLOW CONTROLLER. Classified as Plug, Punctum (product code LZU).

Submitted by Odyssey Medical, Inc. (Bartlett, US). The FDA issued a Cleared decision on June 4, 2009 after a review of 62 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.

FDA 510(k) Submission Details - K090938

510(k) Number K090938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2009
Decision Date June 04, 2009
Days to Decision 62 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
48d faster than avg
Panel avg: 110d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

All 45
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K090938 · FLOW CONTROLLER
Download PDF FDA Summary Odyssey Medical, Inc.