Cleared Traditional

K992476 - PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS (FDA 510(k) Clearance)

Class I Cardiovascular device.

K992476 · Pilling Weck Surgical · Cardiovascular device
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Sep 2000
Decision
415d
Days
Class 1
Risk

K992476 is an FDA 510(k) clearance for the PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS. Classified as Stabilizer, Heart (product code MWS), Class I - General Controls.

Submitted by Pilling Weck Surgical (Fort Washington, US). The FDA issued a Cleared decision on September 13, 2000 after a review of 415 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - 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.

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Submission Details

510(k) Number K992476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1999
Decision Date September 13, 2000
Days to Decision 415 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
290d slower than avg
Panel avg: 125d · This submission: 415d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MWS Stabilizer, Heart
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
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.