Cleared Traditional

K830022 - S.M.P. CONTRAST MEDIA SET

K830022 is an FDA 510(k) clearance for S.M.P. CONTRAST MEDIA SET, manufactured by Omega Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K830022 · Omega Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1983
Decision
17d
Days
Class 2
Risk

K830022 is an FDA 510(k) clearance for the S.M.P. CONTRAST MEDIA SET. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Omega Technologies, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1983 after a review of 17 days - a notably fast clearance cycle.

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: 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 Omega Technologies, Inc. devices

FDA 510(k) Submission Details - K830022

510(k) Number K830022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1983
Decision Date January 21, 1983
Days to Decision 17 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 125d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

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 423
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K830022.
TRANSLUCENT POLY. CATH. CONNECTOR AND
K830237 · Vertex Medical Corp. · Feb 1983
INTRACATH-DA INTRAVENOUS CATH. PLACEMENT
K823064 · Parke-Davis Co. · Jan 1983
SIDEARM Y-ADAPTOR
K823243 · American Edwards Laboratories · Jan 1983
INTRA CATH-DSA INTRAVENOUS CATH PLACE.
K823065 · Parke-Davis Co. · Dec 1982
BRACHIAL CORONARY GUIDING CATHETER
K822862 · Advanced Cardiovascular Systems, Inc. · Oct 1982
POLYETHYLENE CARDIOVASCULAR CATHETER
K822594 · Vertex Medical Corp. · Sep 1982