Cleared Traditional

K854256 - KEELER AMOILS SURGICAL ASTIGOMETER (FDA 510(k) Clearance)

K854256 · Keeler Instruments, Inc. · Ophthalmic device
Dec 1985
Decision
52d
Days
-
Risk

K854256 is an FDA 510(k) clearance for the KEELER AMOILS SURGICAL ASTIGOMETER.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on December 13, 1985 after a review of 52 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.

Submission Details

510(k) Number K854256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1985
Decision Date December 13, 1985
Days to Decision 52 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 156d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -