Cleared Traditional

K944390 - R&D BATTERIES PART NOS. 5141

K944390 is the FDA 510(k) clearance for R&D BATTERIES PART NOS. 5141 by R & D Batteries, Inc.. It is a Class 1 Gastroenterology & Urology device (product code FCO) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K944390 · R & D Batteries, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Feb 1995
Decision
173d
Days
Class 1
Risk

K944390 is an FDA 510(k) clearance for the R&D BATTERIES PART NOS. 5141, 5067, 5118, 5277. Classified as Box, Battery, Rechargeable (product code FCO), Class I - General Controls.

Submitted by R & D Batteries, Inc. (Burnsville, US). The FDA issued a Cleared decision on February 27, 1995 after a review of 173 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all R & D Batteries, Inc. devices

Submission Details

510(k) Number K944390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1994
Decision Date February 27, 1995
Days to Decision 173 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 130d · This submission: 173d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FCO Box, Battery, Rechargeable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.1500
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 - FCO Box, Battery, Rechargeable

All 16
Devices cleared under the same product code (FCO) and FDA review panel - the closest regulatory comparables to K944390.
RECHARGEABLE BATTERIES
K944521 · R & D Batteries, Inc. · Mar 1995
R&D PART NOS. 5262, 5543, 5432, 5469
K945868 · R & D Batteries, Inc. · Mar 1995
R&D BATTERIES PART NOS. 5186 AND 5230
K944387 · R & D Batteries, Inc. · Mar 1995
R&D PART NOS. 5443, 5322, 5448, 5492
K945869 · R & D Batteries, Inc. · Feb 1995
R&D PART NOS. 5339, 5510, 5514
K945871 · R & D Batteries, Inc. · Feb 1995
R&D BATTERIES, INC. PART NUMBERS 5162, 5040, 5237, AND 5102
K944294 · R & D Batteries, Inc. · Dec 1994