Cleared Traditional

K801181 - VAP 2001 (FDA 510(k) Clearance)

K801181 · Blendette Intl. , Ltd. · General Hospital
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Apr 1981
Decision
333d
Days
-
Risk

K801181 is an FDA 510(k) clearance for the VAP 2001.

Submitted by Blendette Intl. , Ltd. (Mchenry, US). The FDA issued a Cleared decision on April 14, 1981 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Blendette Intl. , Ltd. devices

Submission Details

510(k) Number K801181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1980
Decision Date April 14, 1981
Days to Decision 333 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
205d slower than avg
Panel avg: 128d · This submission: 333d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -