Cleared Traditional

K843360 - ARTAP ARTERIAL BLOOD SAMPLING DEVICE

K843360 is the FDA 510(k) clearance for ARTAP ARTERIAL BLOOD SAMPLING DEVICE by Analytical Products, Inc.. It is a Class 1 Hematology device (product code CBT) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K843360 · Analytical Products, Inc. · Hematology device
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Oct 1984
Decision
64d
Days
Class 1
Risk

K843360 is an FDA 510(k) clearance for the ARTAP ARTERIAL BLOOD SAMPLING DEVICE. Classified as Arterial Blood Sampling Kit (product code CBT), Class I - General Controls.

Submitted by Analytical Products, Inc. (Belmont, US). The FDA issued a Cleared decision on October 31, 1984 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 868.1100 - the FDA hematology device framework. 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 Analytical Products, Inc. devices

Submission Details

510(k) Number K843360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1984
Decision Date October 31, 1984
Days to Decision 64 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 113d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CBT Arterial Blood Sampling Kit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.1100
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CBT Arterial Blood Sampling Kit

All 8
Devices cleared under the same product code (CBT) and FDA review panel - the closest regulatory comparables to K843360.
SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT II
K930471 · Sherwood Medical Co. · Jun 1993
UMBILICAL CORD BLOOD SAMPLING KIT
K900302 · Ge Medical Systems Information Technologies · Apr 1990
CIBA CORNING BALANCED HEPARIN FOR CA++
K875117 · Ciba Corning Diagnostics Corp. · Feb 1988
PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY
K812338 · Terumo Medical Corp. · Sep 1981
BARD-PARKER ARTERIAL MONITORING SYSTEM
K780939 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1978