Cleared Traditional

HEMO-ALERT (K893830) - FDA 510(k) Clearance

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

K893830 · Koregon Enterprise, Inc. · Cardiovascular device
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Oct 1989
Decision
141d
Days
Class 2
Risk

K893830 is an FDA 510(k) clearance for the HEMO-ALERT. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Koregon Enterprise, Inc. (Beaverton, US). The FDA issued a Cleared decision on October 12, 1989 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Koregon Enterprise, Inc. devices

Submission Details

510(k) Number K893830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1989
Decision Date October 12, 1989
Days to Decision 141 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 156
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K893830.
CORDIS SHUTTLE CATHETER
K896308 · Cordis Corp. · Mar 1990
MULTILUMEN CENTRAL VENOUS CATHETER
K885221 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F
K894168 · Baxter Healthcare Corp · Nov 1989
INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING
K891580 · Boston Scientific Corp · Aug 1989
USCI 7F GUIDE CATHETER
K890420 · C.R. Bard, Inc. · Apr 1989
USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER
K884502 · C.R. Bard, Inc. · Jan 1989