Cleared Traditional

K952470 - ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.

K952470 is an FDA 510(k) clearance for ACTI-FLEX LOW, manufactured by R-Group Intl.. The device is a Class 1 General & Plastic Surgery device with product code GCD cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K952470 · R-Group Intl. · General & Plastic Surgery device
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Nov 1995
Decision
186d
Days
Class 1
Risk

K952470 is an FDA 510(k) clearance for the ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II.. Classified as Connector, Catheter (product code GCD), Class I - General Controls.

Submitted by R-Group Intl. (Gainesville, US). The FDA issued a Cleared decision on November 28, 1995 after a review of 186 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all R-Group Intl. devices

FDA 510(k) Submission Details - K952470

510(k) Number K952470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1995
Decision Date November 28, 1995
Days to Decision 186 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 115d · This submission: 186d
Pathway characteristics
Predicate-based equivalence.

GCD Device Classification - Class 1, General Controls

Product Code GCD Connector, Catheter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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 - GCD Connector, Catheter

Devices cleared under the same product code (GCD) and FDA review panel - the closest regulatory comparables to K952470.
L-CATH CONNECTOR ASSEMBLY
K940198 · Luther Medical Products, Inc. · Dec 1994
ANGIOMED HIGH PRESSURE CONNECTORS
K863446 · Angiomed U.S., Inc. · Sep 1986
INCISION DRAIN
K851196 · Sil-Med Corp. · Jun 1985
Y CONNECTOR
K851921 · Sil-Med Corp. · May 1985
CATHETER CONNECTOR, ARGYLE TUBING
K760524 · Sherwood Medical Industries · Nov 1976
TUBE, STERILE NON-CONDUCTIVE CONNECTING
K760203 · Ipco Corp. · Jul 1976