Cleared Traditional

K896175 - HERRICK LACRIMAL PLUG TM.

K896175 · Lacrimedics, Inc. · Ophthalmic device
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Jan 1990
Decision
89d
Days
-
Risk

K896175 is an FDA 510(k) clearance for the HERRICK LACRIMAL PLUG TM.. Classified as Plug, Punctum (product code LZU).

Submitted by Lacrimedics, Inc. (Rosemead, US). The FDA issued a Cleared decision on January 22, 1990 after a review of 89 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 - K896175

510(k) Number K896175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1989
Decision Date January 22, 1990
Days to Decision 89 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 110d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

All 48
Devices cleared under the same product code (LZU) and FDA review panel - the closest regulatory comparables to K896175.
OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS
K911108 · G.W.B. Intl., Ltd. · May 1991
LACRIMAL PLUG
K905750 · Tamcenan Corp. · Mar 1991
LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
K897190 · Look, Inc. · Mar 1990
COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TEST
K895342 · Lacrimedics, Inc. · Nov 1989
LACRIMAL EFFICIENCY TEST (TM)
K890714 · Lacrimedics, Inc. · May 1989
TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
K890919 · Eagle Vision, Inc. · May 1989
K896175 · HERRICK LACRIMAL PLUG TM.
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