Cleared Traditional

K833582 - PULSATOR ARTERIAL BLOOD SAMPLING SYRIN

K833582 is the FDA 510(k) clearance for PULSATOR ARTERIAL BLOOD SAMPLING SYRIN by Concord Laboratories, Inc.. It is a Class 1 Anesthesiology device (product code CBT) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K833582 · Concord Laboratories, Inc. · Anesthesiology device
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Dec 1983
Decision
76d
Days
Class 1
Risk

K833582 is an FDA 510(k) clearance for the PULSATOR ARTERIAL BLOOD SAMPLING SYRIN. Classified as Arterial Blood Sampling Kit (product code CBT), Class I - General Controls.

Submitted by Concord Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1983 after a review of 76 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 Concord Laboratories, Inc. devices

Submission Details

510(k) Number K833582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1983
Decision Date December 27, 1983
Days to Decision 76 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 140d · This submission: 76d
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 K833582.
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