Cleared Traditional

K832545 - ARTERIAL BLOOD SAMPLING KIT

K832545 is an FDA 510(k) clearance for ARTERIAL BLOOD SAMPLING KIT, manufactured by Dhd Medical Products Div. Diemolding Corp.. The device is a Class 1 Anesthesiology device with product code CBT cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K832545 · Dhd Medical Products Div. Diemolding Corp. · Anesthesiology device
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Sep 1983
Decision
59d
Days
Class 1
Risk

K832545 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. (Walker, US). The FDA issued a Cleared decision on September 26, 1983 after a review of 59 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

FDA 510(k) Submission Details - K832545

510(k) Number K832545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1983
Decision Date September 26, 1983
Days to Decision 59 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 140d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

CBT Device Classification - Class 1, General Controls

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 39
Devices cleared under the same product code (CBT) and FDA review panel - the closest regulatory comparables to K832545.
VAPORIZED HEPARIN
K840987 · Concord Laboratories, Inc. · Apr 1984
MARZ-175 ARTERIAL BLOOD GAS SYRINGE
K833923 · Chesebrough-Pond'S U.S.A. Co. · Jan 1984
PULSATOR ARTERIAL BLOOD SAMPLING SYRIN
K833582 · Concord Laboratories, Inc. · Dec 1983
OMNISTICK
K830310 · Marquest Medical Products, Inc. · May 1983
AUTO STIK
K830311 · Marquest Medical Products, Inc. · May 1983
ASPIRATOR
K830312 · Marquest Medical Products, Inc. · May 1983