Cleared Traditional

K945867 - R&D PART 5518, 5306, 5315 AND 5457 (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K945867 · R & D Batteries, Inc. · Gastroenterology & Urology device
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Dec 1994
Decision
28d
Days
Class 1
Risk

K945867 is an FDA 510(k) clearance for the R&D PART 5518, 5306, 5315 AND 5457. 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 December 29, 1994 after a review of 28 days - a notably fast clearance 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: 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 K945867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1994
Decision Date December 29, 1994
Days to Decision 28 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 130d · This submission: 28d
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.