Cleared Traditional

K820125 - COBE CENTRY 2000 RX (FDA 510(k) Clearance)

K820125 · Cobe Laboratories, Inc. · Gastroenterology & Urology device
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Mar 1982
Decision
64d
Days
-
Risk

K820125 is an FDA 510(k) clearance for the COBE CENTRY 2000 RX.

Submitted by Cobe Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1982 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology 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 Cobe Laboratories, Inc. devices

Submission Details

510(k) Number K820125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1982
Decision Date March 23, 1982
Days to Decision 64 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 130d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -