Cleared Traditional

RDI CARDIAC INSULATION PAD (K960312) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K960312 · R D Intl. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
88d
Days
Class 2
Risk

K960312 is an FDA 510(k) clearance for the RDI CARDIAC INSULATION PAD. Classified as Dilator, Vessel, Surgical (product code DWP), Class II - Special Controls.

Submitted by R D Intl. (Richardson, US). The FDA issued a Cleared decision on April 19, 1996 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4475 - 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: 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 D Intl. devices

Submission Details

510(k) Number K960312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1996
Decision Date April 19, 1996
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWP Dilator, Vessel, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4475
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 - DWP Dilator, Vessel, Surgical

Devices cleared under the same product code (DWP) and FDA review panel - the closest regulatory comparables to K960312.
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
K220981 · Fehling Surgical Instruments, Inc. · Apr 2023
Geomed Vascular Dilators
K183438 · Geomed Medizin-Technik GmbH & Co. · Sep 2019
FOGARTY VESSEL CALIBRATOR
K902143 · Baxter Healthcare Corp · Oct 1990
VESSEL DILATOR
K832595 · Abbott Laboratories · Aug 1983
BONCHEK-SHILEY VEIN DISTENTION SYSTEM
K792134 · Shiley, Inc. · Dec 1979
SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO
K790938 · Shiley, Inc. · Jun 1979