Cleared Traditional

K931873 - VACVENT

K931873 is the FDA 510(k) clearance for VACVENT by Steven Frank Mercereau. It is a Class 1 Anesthesiology device (product code CBT) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K931873 · Steven Frank Mercereau · Anesthesiology device
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Dec 1993
Decision
260d
Days
Class 1
Risk

K931873 is an FDA 510(k) clearance for the VACVENT. Classified as Arterial Blood Sampling Kit (product code CBT), Class I - General Controls.

Submitted by Steven Frank Mercereau (Conyers, US). The FDA issued a Cleared decision on December 30, 1993 after a review of 260 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Steven Frank Mercereau devices

Submission Details

510(k) Number K931873 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received April 14, 1993
Decision Date December 30, 1993
Days to Decision 260 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 140d · This submission: 260d
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 K931873.
ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM
K945719 · Sherwood Medical Co. · Mar 1995
ASPIR-PULSE(TM) SAF-T-VENT
K940575 · Sherwood Medical Co. · Mar 1994
SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I
K925453 · Sherwood Medical Co. · Jul 1993
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