Cleared Traditional

K897021 - MARTIN-HENSLEY SEGMENT LENS

K897021 · Bruce W. Martin O.D. and Edward Hensley · Ophthalmic device
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Jun 1990
Decision
185d
Days
-
Risk

K897021 is an FDA 510(k) clearance for the MARTIN-HENSLEY SEGMENT LENS. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Bruce W. Martin O.D. and Edward Hensley (Gladwin, US). The FDA issued a Cleared decision on June 22, 1990 after a review of 185 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.

View all Bruce W. Martin O.D. and Edward Hensley devices

FDA 510(k) Submission Details - K897021

510(k) Number K897021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1989
Decision Date June 22, 1990
Days to Decision 185 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 110d · This submission: 185d
Pathway characteristics
Predicate-based equivalence.

HPX Device Classification - Class 0,

Product Code HPX Lens, Contact (polymethylmethacrylate)
Device Class -

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 20
Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K897021.
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LENSKEEPER CONTACT LENS CARRYING CASE
K861642 · Allergan, Inc. · May 1986
BAUSCH & LOMB LENS CARRYING CASE
K854968 · Bausch & Lomb, Inc. · Apr 1986
SIGHT SAVER ALL PURPOSE LENS CARRYING CASE
K852384 · Bausch & Lomb, Inc. · Jul 1985
SENSITIVE EYES
K832706 · Bausch & Lomb, Inc. · Oct 1983