Cleared Traditional

IBM 5880 ACQUISITION & ANALYSIS CART TEL (K810989) - FDA 510(k) Clearance

K810989 · Intl. Business Machines · Cardiovascular device
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May 1981
Decision
18d
Days
-
Risk

K810989 is an FDA 510(k) clearance for the IBM 5880 ACQUISITION & ANALYSIS CART TEL.

Submitted by Intl. Business Machines (Walker, US). The FDA issued a Cleared decision on May 1, 1981 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel. 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 Intl. Business Machines devices

Submission Details

510(k) Number K810989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1981
Decision Date May 01, 1981
Days to Decision 18 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 125d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 82
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