Cleared Traditional

K790455 - MICROFLUSH

K790455 is the FDA 510(k) clearance for MICROFLUSH by Medex, Inc.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K790455 · Medex, Inc. · Cardiovascular device
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Mar 1979
Decision
18d
Days
Class 2
Risk

K790455 is an FDA 510(k) clearance for the MICROFLUSH. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Medex, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1979 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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 Medex, Inc. devices

Submission Details

510(k) Number K790455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1979
Decision Date March 23, 1979
Days to Decision 18 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 125d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 127
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K790455.
MEDI-TRACE
K811410 · Graphic Controls Corp. · Jun 1981
MEDI-TRACE DISP. FLUSHING DEV./MONITOR
K801829 · Graphic Controls Corp. · Aug 1980
CONTINUOUS FLUSH DEVICE, CAT. #14-370
K791890 · Norton Performance Plastics Corp. · Dec 1979
MICROFLUSH
K770432 · Medex, Inc. · Mar 1977
FLUSHFLO-MODEL CC1-6
K761273 · Bentley Laboratories, Inc. · Jan 1977