Cleared Traditional

K954035 - ACTI-FLEX ARTERIAL EXTENSION SET

K954035 is an FDA 510(k) clearance for ACTI-FLEX ARTERIAL EXTENSION SET, manufactured by R-Group Intl.. The device is a Class 1 Anesthesiology device with product code CBT cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K954035 · R-Group Intl. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
28d
Days
Class 1
Risk

K954035 is an FDA 510(k) clearance for the ACTI-FLEX ARTERIAL EXTENSION SET. Classified as Arterial Blood Sampling Kit (product code CBT), Class I - General Controls.

Submitted by R-Group Intl. (Gainesville, US). The FDA issued a Cleared decision on September 25, 1995 after a review of 28 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 R-Group Intl. devices

FDA 510(k) Submission Details - K954035

510(k) Number K954035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1995
Decision Date September 25, 1995
Days to Decision 28 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
112d faster than avg
Panel avg: 140d · This submission: 28d
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 40
Devices cleared under the same product code (CBT) and FDA review panel - the closest regulatory comparables to K954035.
SECURE ARTERIAL BLOOD SAMPLING SYSTEM
K070340 · Smiths Medical Asd, Inc. · Mar 2007
ABC IN-LINE BLOOD SAMPLING KIT
K955663 · Utah Medical Products, Inc. · Mar 1997
ABG POINT LOK NEEDLE PROTECTION DEVICE
K954015 · Devon Industries, Inc. · Nov 1995
ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM
K945719 · Sherwood Medical Co. · Mar 1995
ABG NEEDLE PROTECTION
K945485 · Devon Industries, Inc. · Nov 1994
ASPIR-PULSE(TM) SAF-T-VENT
K940575 · Sherwood Medical Co. · Mar 1994