Cleared Traditional

K900849 - CARDISUNY, 501BX

K900849 · Graham-Field, Inc. · Cardiovascular device
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Apr 1990
Decision
41d
Days
-
Risk

K900849 is an FDA 510(k) clearance for the CARDISUNY, 501BX.

Submitted by Graham-Field, Inc. (Hauppauge, US). The FDA issued a Cleared decision on April 4, 1990 after a review of 41 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 Graham-Field, Inc. devices

FDA 510(k) Submission Details - K900849

510(k) Number K900849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1990
Decision Date April 04, 1990
Days to Decision 41 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 125d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 53
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