Cleared Traditional

SCANLAN VASCU-STATT II (K841515) - FDA 510(k) Clearance

Class I Ophthalmic device.

K841515 · Scanlan Intl., Inc. · Ophthalmic device
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Jun 1984
Decision
54d
Days
Class 1
Risk

K841515 is an FDA 510(k) clearance for the SCANLAN VASCU-STATT II. Classified as Engine, Trephine, Accessories, Ac-powered (product code HRG), Class I - General Controls.

Submitted by Scanlan Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 5, 1984 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4070 - the FDA ophthalmic device framework. 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 Scanlan Intl., Inc. devices

Submission Details

510(k) Number K841515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1984
Decision Date June 05, 1984
Days to Decision 54 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 110d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HRG Engine, Trephine, Accessories, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4070
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.