Cleared Traditional

K942712 - NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A

K942712 is an FDA 510(k) clearance for NEITZ HALOGEN BINOCULAR INDIRECT OPHTHA..., manufactured by Neitz Instruments Company, Ltd.. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K942712 · Neitz Instruments Company, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
57d
Days
Class 2
Risk

K942712 is an FDA 510(k) clearance for the NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Neitz Instruments Company, Ltd. (Washington, US). The FDA issued a Cleared decision on August 5, 1994 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - 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 - K942712

510(k) Number K942712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1994
Decision Date August 05, 1994
Days to Decision 57 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
53d faster than avg
Panel avg: 110d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLI Device Classification - Class 2, Special Controls

Product Code HLI Ophthalmoscope, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HLI Ophthalmoscope, Ac-powered

All 72
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K942712.
INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV
K951338 · Neitz Instruments Company, Ltd. · Apr 1995
WELCH ALLYN OPHTHALMOSCOPE
K950461 · Welch Allyn, Inc. · Apr 1995
NEITZ HALOGEN OPHTHALMOSCOPE BXA-123
K942711 · Neitz Instruments Company, Ltd. · Aug 1994
NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H
K942713 · Neitz Instruments Company, Ltd. · Aug 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-RP
K942714 · Neitz Instruments Company, Ltd. · Aug 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC
K942715 · Neitz Instruments Company, Ltd. · Aug 1994