Cleared Traditional

K901382 - ISOFLO(TM) HIGH PRESSURE INJECTION LINES

K901382 is an FDA 510(k) clearance for ISOFLO(TM) HIGH PRESSURE INJECTION LINES, manufactured by Healthdyne Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K901382 · Healthdyne Cardiovascular, Inc. · Cardiovascular device
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Jul 1990
Decision
119d
Days
Class 2
Risk

K901382 is an FDA 510(k) clearance for the ISOFLO(TM) HIGH PRESSURE INJECTION LINES. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Healthdyne Cardiovascular, Inc. (Irvine, US). The FDA issued a Cleared decision on July 19, 1990 after a review of 119 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 Healthdyne Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K901382

510(k) Number K901382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1990
Decision Date July 19, 1990
Days to Decision 119 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 125d · This submission: 119d
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 112
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K901382.
LIQUID DETECTOR
K903495 · Life-Tech Intl., Inc. · Oct 1990
MEDRAD MARK V-PLUS INJECTOR
K903390 · Medrad, Inc. · Sep 1990
MODIFIED ANGIOGRAPHIC INJECTOR AND SYRINGE
K902221 · Mallinckrodt Group, Inc. · Aug 1990
B-D ANGIOGRAPHIC CONTROL SYRINGE
K895318 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1990
USCI PRESTO DISPOSABLE INFLATION DEVICE
K896415 · C.R. Bard, Inc. · Jan 1990
HIGH PRESSURE CONNECTING SETS
K890208 · E-Z-Em, Inc. · May 1989