Cleared Traditional

CARDIAC THERAPHY SYSTEM SCP 900 (K921666) - FDA 510(k) Clearance

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

K921666 · Ppg Hellige B.V. · Cardiovascular device
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Sep 1993
Decision
534d
Days
Class 2
Risk

K921666 is an FDA 510(k) clearance for the CARDIAC THERAPHY SYSTEM SCP 900. Classified as Dc-defibrillator, Low-energy, (including Paddles) (product code LDD), Class II - Special Controls.

Submitted by Ppg Hellige B.V. (Lenexa, US). The FDA issued a Cleared decision on September 23, 1993 after a review of 534 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Ppg Hellige B.V. devices

Submission Details

510(k) Number K921666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1992
Decision Date September 23, 1993
Days to Decision 534 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
409d slower than avg
Panel avg: 125d · This submission: 534d
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 165
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