Cleared Traditional

K821406 - ARTERIAL BLOOD SAMPLING KIT (FDA 510(k) Clearance)

Class I Anesthesiology device.

K821406 · Dhd Medical Products Div. Diemolding Corp. · Anesthesiology device
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Jun 1982
Decision
45d
Days
Class 1
Risk

K821406 is an FDA 510(k) clearance for the ARTERIAL BLOOD SAMPLING KIT. Classified as Arterial Blood Sampling Kit (product code CBT), Class I - General Controls.

Submitted by Dhd Medical Products Div. Diemolding Corp. (Mchenry, US). The FDA issued a Cleared decision on June 25, 1982 after a review of 45 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 Dhd Medical Products Div. Diemolding Corp. devices

Submission Details

510(k) Number K821406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1982
Decision Date June 25, 1982
Days to Decision 45 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 139d · This submission: 45d
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.