Cleared Traditional

K943632 - REPLACEMENT BATTERIES

K943632 is an FDA 510(k) clearance for REPLACEMENT BATTERIES, manufactured by National Custom Ent., Inc.. The device is a Class 1 Gastroenterology & Urology device with product code FCO cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K943632 · National Custom Ent., Inc. · Gastroenterology & Urology device
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Nov 1994
Decision
101d
Days
Class 1
Risk

K943632 is an FDA 510(k) clearance for the REPLACEMENT BATTERIES. Classified as Box, Battery, Rechargeable (product code FCO), Class I - General Controls.

Submitted by National Custom Ent., Inc. (Burnsville, US). The FDA issued a Cleared decision on November 4, 1994 after a review of 101 days - within the typical 510(k) review window.

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 National Custom Ent., Inc. devices

FDA 510(k) Submission Details - K943632

510(k) Number K943632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1994
Decision Date November 04, 1994
Days to Decision 101 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
29d faster than avg
Panel avg: 130d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

FCO Device Classification - Class 1, General Controls

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 17
Devices cleared under the same product code (FCO) and FDA review panel - the closest regulatory comparables to K943632.
R&D BATTERIES, INC. PART NUMBERS 5162, 5040, 5237, AND 5102
K944294 · R & D Batteries, Inc. · Dec 1994
R&D BATTERIES PART NOS. 5354 AND 5150
K944386 · R & D Batteries, Inc. · Dec 1994
R&D PART 5518, 5306, 5315 AND 5457
K945867 · R & D Batteries, Inc. · Dec 1994
R&D BATTERIES, PART NO. 5025, 5128 AND 5183
K942018 · R & D Batteries, Inc. · Jul 1994
R AND D BATTERIES, INC. PART NUMBER 5017
K933449 · R & D Batteries, Inc. · Mar 1994
R & D BATTERIES, INC. PART NUMBER 5047
K935472 · R & D Batteries, Inc. · Feb 1994