Cleared Traditional

K921765 - PRIMEDIC DEFIBRILLATORS-N/B

K921765 is an FDA 510(k) clearance for PRIMEDIC DEFIBRILLATORS-N/B, manufactured by Metronic Electronic GmbH. The device is a Class 2 Cardiovascular device with product code LDD cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K921765 · Metronic Electronic GmbH · Cardiovascular device
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Mar 1993
Decision
323d
Days
Class 2
Risk

K921765 is an FDA 510(k) clearance for the PRIMEDIC DEFIBRILLATORS-N/B. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Metronic Electronic GmbH (Hampton, US). The FDA issued a Cleared decision on March 3, 1993 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Metronic Electronic GmbH devices

FDA 510(k) Submission Details - K921765

510(k) Number K921765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1992
Decision Date March 03, 1993
Days to Decision 323 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 125d · This submission: 323d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDD Device Classification - Class 2, Special Controls

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 117
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