Cleared Traditional

ABG POINT LOK NEEDLE PROTECTION DEVICE (K954015) - FDA 510(k) Clearance

Class I Anesthesiology device.

K954015 · Devon Industries, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
87d
Days
Class 1
Risk

K954015 is an FDA 510(k) clearance for the ABG POINT LOK NEEDLE PROTECTION DEVICE. Classified as Arterial Blood Sampling Kit (product code CBT), Class I - General Controls.

Submitted by Devon Industries, Inc. (Chatsworth, US). The FDA issued a Cleared decision on November 20, 1995 after a review of 87 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 Devon Industries, Inc. devices

Submission Details

510(k) Number K954015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1995
Decision Date November 20, 1995
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
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

Devices cleared under the same product code (CBT) and FDA review panel - the closest regulatory comparables to K954015.
ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM
K945719 · Sherwood Medical Co. · Mar 1995
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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
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