Cleared Traditional

FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 (K090621) - FDA 510(k) Clearance

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

K090621 · Flowcardia, Inc. · Cardiovascular device
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Jun 2009
Decision
102d
Days
Class 2
Risk

K090621 is an FDA 510(k) clearance for the FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Flowcardia, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 19, 2009 after a review of 102 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 Flowcardia, Inc. devices

Submission Details

510(k) Number K090621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2009
Decision Date June 19, 2009
Days to Decision 102 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
23d faster than avg
Panel avg: 125d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 209
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K090621.
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