Cleared Traditional

K883840 - DRI-VENT ARTERIAL BLOOD SAMPLING KIT

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

FDA 510(k) Submission Details - K883840

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 129d · This submission: 246d
Pathway characteristics
Predicate-based equivalence.

LKB Device Classification - Class 0,

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

Regulatory Peers - LKB Pad, Alcohol, Device Disinfectant

All 11
Devices cleared under the same product code (LKB) and FDA review panel - the closest regulatory comparables to K883840.
HEXIDIS ALCOHOL SWAB
K910735 · Specialites Septodont · Apr 1991
BAXTER ACETONE-ALCOHOL PREP PADS, STERILE
K893958 · Span-America Medical Systems, Inc. · Oct 1989
BAXTER ACETONE-ALCOHOL SWABSTICK, STERILE
K894791 · Span-America Medical Systems, Inc. · Oct 1989
PRE-MOISTENED CLEANSING PAD
K890514 · Bausch & Lomb, Inc. · Apr 1989
AMERICAN ALCOHOL PREP PAD STERILE MEDIUM
K870718 · Span-America Medical Systems, Inc. · May 1987
ACETONE ALCOHOL SWABS
K833936 · Concord Laboratories, Inc. · Jan 1984