Cleared Traditional

K964338 - RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-...

K964338 is an FDA 510(k) clearance for RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-..., manufactured by Rudolf Riester GmbH & Co. KG. The device is a Class 1 Ophthalmic device with product code HKM cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K964338 · Rudolf Riester GmbH & Co. KG · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K964338

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 110d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

HKM Device Classification - Class 1, General Controls

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.

Regulatory Peers - HKM Retinoscope, Battery-powered

Devices cleared under the same product code (HKM) and FDA review panel - the closest regulatory comparables to K964338.
STREAK RETINOSCOPE RX-3
K950791 · Neitz Instruments Company, Ltd. · Mar 1995
STREAK RETINOSCOPE RX-3A
K950792 · Neitz Instruments Company, Ltd. · Mar 1995
SPOT RETINOSCOPE RX-3SP
K950793 · Neitz Instruments Company, Ltd. · Mar 1995
STREAK RETINOSCOPE RX-RC
K950794 · Neitz Instruments Company, Ltd. · Mar 1995
STREAK RETINOSCOPE RX-RP
K950795 · Neitz Instruments Company, Ltd. · Mar 1995