Cleared Traditional

FIBERGLASS CYLINDER BASES, #'S 65040- (K800665) - FDA 510(k) Clearance

K800665 · B & F Medical Products, Inc. · Cardiovascular device
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Apr 1980
Decision
7d
Days
-
Risk

K800665 is an FDA 510(k) clearance for the FIBERGLASS CYLINDER BASES, #'S 65040-.

Submitted by B & F Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 2, 1980 after a review of 7 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 B & F Medical Products, Inc. devices

Submission Details

510(k) Number K800665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1980
Decision Date April 02, 1980
Days to Decision 7 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 125d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -