Cleared Traditional

ALSITE MAGNIVISION (K772228) - FDA 510(k) Clearance

K772228 · Al Nyman & Son, Inc. · Ophthalmic device
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Jan 1978
Decision
28d
Days
-
Risk

K772228 is an FDA 510(k) clearance for the ALSITE MAGNIVISION.

Submitted by Al Nyman & Son, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1978 after a review of 28 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 Al Nyman & Son, Inc. devices

Submission Details

510(k) Number K772228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1977
Decision Date January 03, 1978
Days to Decision 28 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 110d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -