Cleared Traditional

K801435 - ORGANON ARTERIAL BLOOD SAMPLER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K801435 · Akzona, Inc. · Anesthesiology device
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Jul 1980
Decision
29d
Days
Class 1
Risk

K801435 is an FDA 510(k) clearance for the ORGANON ARTERIAL BLOOD SAMPLER. Classified as Arterial Blood Sampling Kit (product code CBT), Class I - General Controls.

Submitted by Akzona, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1980 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1100 - the FDA anesthesiology and respiratory 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 Akzona, Inc. devices

Submission Details

510(k) Number K801435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1980
Decision Date July 18, 1980
Days to Decision 29 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 139d · This submission: 29d
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.