Cleared Traditional

K964338 - RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT (FDA 510(k) Clearance)

Class I Ophthalmic device.

K964338 · Rudolf Riester GmbH & Co. KG · Ophthalmic device
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Jan 1997
Decision
70d
Days
Class 1
Risk

K964338 is an FDA 510(k) clearance for the RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT. Classified as Retinoscope, Battery-powered (product code HKM), Class I - General Controls.

Submitted by Rudolf Riester GmbH & Co. KG (D-72417 Jungingen, DE). The FDA issued a Cleared decision on January 9, 1997 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1780 - 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 Rudolf Riester GmbH & Co. KG devices

Submission Details

510(k) Number K964338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1996
Decision Date January 09, 1997
Days to Decision 70 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 110d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HKM Retinoscope, Battery-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1780
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.