Cleared Traditional

K883840 - DRI-VENT ARTERIAL BLOOD SAMPLING KIT (FDA 510(k) Clearance)

K883840 · Concord Laboratories, Inc. · General Hospital
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May 1989
Decision
246d
Days
-
Risk

K883840 is an FDA 510(k) clearance for the DRI-VENT ARTERIAL BLOOD SAMPLING KIT. Classified as Pad, Alcohol, Device Disinfectant (product code LKB).

Submitted by Concord Laboratories, Inc. (Keene, US). The FDA issued a Cleared decision on May 16, 1989 after a review of 246 days - an extended review cycle.

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. Standard predicate reliance. 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 Concord Laboratories, Inc. devices

Submission Details

510(k) Number K883840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received September 12, 1988
Decision Date May 16, 1989
Days to Decision 246 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
118d slower than avg
Panel avg: 128d · This submission: 246d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKB Pad, Alcohol, Device Disinfectant
Device Class -