Cleared Traditional

K950914 - RI-FORMER WALL MODEL 2

K950914 is an FDA 510(k) clearance for RI-FORMER WALL MODEL 2, manufactured by Rudolf Riester GmbH & Co. KG. The device is a Class 2 Ophthalmic device with product code HLJ cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K950914 · Rudolf Riester GmbH & Co. KG · Ophthalmic device
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Jul 1995
Decision
151d
Days
Class 2
Risk

K950914 is an FDA 510(k) clearance for the RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANA.... Classified as Ophthalmoscope, Battery-powered (product code HLJ), Class II - Special Controls.

Submitted by Rudolf Riester GmbH & Co. KG (D-72417 Jungingen, DE). The FDA issued a Cleared decision on July 24, 1995 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Rudolf Riester GmbH & Co. KG devices

FDA 510(k) Submission Details - K950914

510(k) Number K950914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1995
Decision Date July 24, 1995
Days to Decision 151 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
41d slower than avg
Panel avg: 110d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLJ Device Classification - Class 2, Special Controls

Product Code HLJ Ophthalmoscope, Battery-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 - HLJ Ophthalmoscope, Battery-powered

All 23
Devices cleared under the same product code (HLJ) and FDA review panel - the closest regulatory comparables to K950914.
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
K032087 · Keeler Instruments, Inc. · Nov 2003
MS401097-17,MS722-K,MS720,MS721,MS722
K962767 · Alexander Mfg. Co. · Jul 1997
KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
K970029 · Keeler Instruments, Inc. · Apr 1997
HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134
K950797 · Neitz Instruments Company, Ltd. · Mar 1995
HALOGEN DIAGNOSTIC SET BX A - 12345
K950796 · Neitz Instruments Company, Ltd. · Mar 1995
RI-SCOPE S OTOSCOPE
K945640 · Rudolf Riester GmbH & Co. KG · Jan 1995