Cleared Traditional

COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC (K900105) - FDA 510(k) Clearance

K900105 · Cobe Laboratories, Inc. · Gastroenterology & Urology device
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Mar 1991
Decision
437d
Days
-
Risk

K900105 is an FDA 510(k) clearance for the COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC. Classified as Separator, Automated, Blood Cell And Plasma, Therapeutic (product code LKN).

Submitted by Cobe Laboratories, Inc. (Lakewood, US). The FDA issued a Cleared decision on March 22, 1991 after a review of 437 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Cobe Laboratories, Inc. devices

Submission Details

510(k) Number K900105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1990
Decision Date March 22, 1991
Days to Decision 437 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
307d slower than avg
Panel avg: 130d · This submission: 437d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Device Class -

Regulatory Peers - LKN Separator, Automated, Blood Cell And Plasma, Therapeutic

All 8
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