Cleared Traditional

K942034 - R&D BATTERIES

K942034 is the FDA 510(k) clearance for R&D BATTERIES by R & D Batteries, Inc.. It is a Class 2 Ophthalmic device (product code HLJ) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K942034 · R & D Batteries, Inc. · Ophthalmic device
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Jun 1994
Decision
36d
Days
Class 2
Risk

K942034 is an FDA 510(k) clearance for the R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502. Classified as Ophthalmoscope, Battery-powered (product code HLJ), Class II - Special Controls.

Submitted by R & D Batteries, Inc. (Burnsville, US). The FDA issued a Cleared decision on June 3, 1994 after a review of 36 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 R & D Batteries, Inc. devices

Submission Details

510(k) Number K942034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1994
Decision Date June 03, 1994
Days to Decision 36 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
74d faster than avg
Panel avg: 110d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 18
Devices cleared under the same product code (HLJ) and FDA review panel - the closest regulatory comparables to K942034.
KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
K970029 · Keeler Instruments, Inc. · Apr 1997
RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V
K950914 · Rudolf Riester GmbH & Co. KG · Jul 1995
RI-SCOPE S OTOSCOPE
K945640 · Rudolf Riester GmbH & Co. KG · Jan 1995
REPLACEMENT BATTERIES PART NO. 5098,5135, 5097
K936018 · R & D Batteries, Inc. · Feb 1994
R & D BATTERIES
K936104 · R & D Batteries, Inc. · Feb 1994
DE LUXE
K925755 · Rudolf Riester GmbH & Co. KG · Dec 1993