Cleared Traditional

K881279 - EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET (FDA 510(k) Clearance)

Class I Cardiovascular device.

K881279 · Baxter Healthcare Corp · Cardiovascular device
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May 1988
Decision
57d
Days
Class 1
Risk

K881279 is an FDA 510(k) clearance for the EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET. Classified as Sizer, Heart-valve, Prosthesis (product code DTI), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on May 18, 1988 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3945 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K881279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1988
Decision Date May 18, 1988
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTI Sizer, Heart-valve, Prosthesis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.3945
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.