Cleared Traditional

K913267 - R-GROUP INTL. ONE WALL PUNCTURE NEEDLE

K913267 is an FDA 510(k) clearance for R-GROUP INTL. ONE WALL PUNCTURE NEEDLE, manufactured by R-Group Intl.. The device is a Class 2 Cardiovascular device with product code DRC cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K913267 · R-Group Intl. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
318d
Days
Class 2
Risk

K913267 is an FDA 510(k) clearance for the R-GROUP INTL. ONE WALL PUNCTURE NEEDLE. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by R-Group Intl. (Gainesville, US). The FDA issued a Cleared decision on June 5, 1992 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1390 - the FDA cardiovascular device oversight 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all R-Group Intl. devices

FDA 510(k) Submission Details - K913267

510(k) Number K913267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1991
Decision Date June 05, 1992
Days to Decision 318 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 125d · This submission: 318d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRC Device Classification - Class 2, Special Controls

Product Code DRC Trocar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1390
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DRC Trocar

All 41
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K913267.
HEARTPORT NEEDLE TROCAR
K965051 · Heartport, Inc. · Mar 1997
GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE
K951448 · Global Medical Products, Ltd. · Mar 1996
ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE
K924338 · Arrow Intl., Inc. · Mar 1993
DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION
K914985 · E-Z-Em, Inc. · Dec 1991
LAPAROSCOPIC TROCAR
K911483 · United States Endoscopy Group, Inc. · Jul 1991
SELDINGER SINGLE WALL
K895454 · Advance Medical Designs, Inc. · Nov 1989