Cleared Traditional

K881449 - EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116 (FDA 510(k) Clearance)

Class I Cardiovascular device.

K881449 · Baxter Healthcare Corp · Cardiovascular device
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Jun 1988
Decision
71d
Days
Class 1
Risk

K881449 is an FDA 510(k) clearance for the EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116. Classified as Probe, Test, Heart-valve (product code LXN), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on June 15, 1988 after a review of 71 days - a notably fast clearance cycle.

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: 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 K881449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1988
Decision Date June 15, 1988
Days to Decision 71 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXN Probe, Test, Heart-valve
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.