Cleared Traditional

K911549 - INJECTOR FILL TUBE

K911549 is an FDA 510(k) clearance for INJECTOR FILL TUBE, manufactured by The R Group. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K911549 · The R Group · Cardiovascular device
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Jul 1991
Decision
101d
Days
Class 2
Risk

K911549 is an FDA 510(k) clearance for the INJECTOR FILL TUBE. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by The R Group (Gainesvilles, US). The FDA issued a Cleared decision on July 18, 1991 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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. Standard predicate reliance. 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 The R Group devices

FDA 510(k) Submission Details - K911549

510(k) Number K911549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1991
Decision Date July 18, 1991
Days to Decision 101 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 125d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - DXT Injector And Syringe, Angiographic

All 176
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K911549.
CT 8000 DIGITAL INJECTION SYSTEM
K912944 · Mallinckrodt Group, Inc. · Feb 1992
TRAC-WRIGHT SYSTEM, MODEL TW2
K910594 · Dow Corning Wright · Sep 1991
MEDRAD VARIBLE INFUSION INJECTOR
K905819 · Medrad, Inc. · Sep 1991
BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP
K910873 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1991
CLOSED SYSTEM FLUSH SET
K904994 · Argon Medical Corp. · Jan 1991
HIGH-PRESSURE CONNECTOR TUBE
K904212 · Mallinckrodt Medical · Dec 1990