Cleared Traditional

K950793 - SPOT RETINOSCOPE RX-3SP

K950793 is an FDA 510(k) clearance for SPOT RETINOSCOPE RX-3SP, manufactured by Neitz Instruments Company, Ltd.. The device is a Class 1 Ophthalmic device with product code HKM cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K950793 · Neitz Instruments Company, Ltd. · Ophthalmic device
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Mar 1995
Decision
35d
Days
Class 1
Risk

K950793 is an FDA 510(k) clearance for the SPOT RETINOSCOPE RX-3SP. Classified as Retinoscope, Battery-powered (product code HKM), Class I - General Controls.

Submitted by Neitz Instruments Company, Ltd. (Tokyo, JP). The FDA issued a Cleared decision on March 28, 1995 after a review of 35 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 Neitz Instruments Company, Ltd. devices

FDA 510(k) Submission Details - K950793

510(k) Number K950793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1995
Decision Date March 28, 1995
Days to Decision 35 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
75d faster than avg
Panel avg: 110d · This submission: 35d
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 K950793.
RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT
K964338 · Rudolf Riester GmbH & Co. KG · Jan 1997
STREAK RETINOSCOPE RX-3
K950791 · Neitz Instruments Company, Ltd. · Mar 1995
STREAK RETINOSCOPE RX-3A
K950792 · 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