Cleared Traditional

K945719 - ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM (FDA 510(k) Clearance)

Class I Anesthesiology device.

K945719 · Sherwood Medical Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
115d
Days
Class 1
Risk

K945719 is an FDA 510(k) clearance for the ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM. Classified as Arterial Blood Sampling Kit (product code CBT), Class I - General Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on March 16, 1995 after a review of 115 days - within the typical 510(k) review window.

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 Sherwood Medical Co. devices

Submission Details

510(k) Number K945719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 21, 1994
Decision Date March 16, 1995
Days to Decision 115 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 139d · This submission: 115d
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.