Cleared Traditional

NCE REPLACEMENT BATTERIES (K941995) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K941995 · National Custom Ent., Inc. · Cardiovascular device
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Jul 1994
Decision
92d
Days
Class 2
Risk

K941995 is an FDA 510(k) clearance for the NCE REPLACEMENT BATTERIES. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by National Custom Ent., Inc. (Burnsville, US). The FDA issued a Cleared decision on July 26, 1994 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5300 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all National Custom Ent., Inc. devices

Submission Details

510(k) Number K941995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received April 25, 1994
Decision Date July 26, 1994
Days to Decision 92 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDD Dc-defibrillator, Low-energy, (including Paddles)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5300
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - LDD Dc-defibrillator, Low-energy, (including Paddles)

All 10
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