Cleared Traditional

K811860 - EASY-FLO ARTERIAL BLOOD GAS KIT

K811860 is the FDA 510(k) clearance for EASY-FLO ARTERIAL BLOOD GAS KIT by Dhd Medical Products Div. Diemolding Corp.. It is a Class 1 Anesthesiology device (product code CBT) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K811860 · Dhd Medical Products Div. Diemolding Corp. · Anesthesiology device
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Jul 1981
Decision
15d
Days
Class 1
Risk

K811860 is an FDA 510(k) clearance for the EASY-FLO ARTERIAL BLOOD GAS 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 July 16, 1981 after a review of 15 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 K811860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1981
Decision Date July 16, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 140d · This submission: 15d
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 K811860.
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