Cleared Traditional

K193012 - speX Support Catheter

K193012 is an FDA 510(k) clearance for speX Support Catheter, manufactured by Reflow Medical. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K193012 · Reflow Medical · Cardiovascular device
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Feb 2020
Decision
113d
Days
Class 2
Risk

K193012 is an FDA 510(k) clearance for the speX Support Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Reflow Medical (San Clemente, US). The FDA issued a Cleared decision on February 19, 2020 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Reflow Medical devices

FDA 510(k) Submission Details - K193012

510(k) Number K193012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2019
Decision Date February 19, 2020
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 621
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K193012.
NovaCross CTO Microcatheter
K193322 · Nitiloop , Ltd. · Apr 2020
speX LP Support Catheter
K200094 · Reflow Medical · Mar 2020
Wingman 14, Wingman 14C, Wingman 18, Wingman 35
K193596 · Reflow Medical · Feb 2020
TrapIt
K191229 · Imds Operations B.V. · Jan 2020
Route 92 Medical Sheath System
K191717 · Route 92 Medical, Inc. · Jan 2020
BioCardia 8F Morph DNA Deflectable Guide Catheter
K192774 · Biocardia · Jan 2020