Cleared Traditional

MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB (K904556) - FDA 510(k) Clearance

Class I Physical Medicine device.

K904556 · Boston Scientific Corp · Physical Medicine device
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Dec 1991
Decision
439d
Days
Class 1
Risk

K904556 is an FDA 510(k) clearance for the MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB. Classified as Treadmill, Powered (product code IOL), Class I - General Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on December 18, 1991 after a review of 439 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5380 - the FDA physical medicine 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: 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 Physical Medicine submissions.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K904556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1990
Decision Date December 18, 1991
Days to Decision 439 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
324d slower than avg
Panel avg: 115d · This submission: 439d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IOL Treadmill, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5380
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.