Cleared Traditional

Bullfrog Micro-Infusion Device (K153501) - FDA 510(k) Clearance

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

K153501 · Mercator Medsystems, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2016
Decision
130d
Days
Class 2
Risk

K153501 is an FDA 510(k) clearance for the Bullfrog Micro-Infusion Device. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Mercator Medsystems, Inc. (Emeryville, US). The FDA issued a Cleared decision on April 15, 2016 after a review of 130 days - within the typical 510(k) review window.

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: 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 Mercator Medsystems, Inc. devices

Submission Details

510(k) Number K153501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2015
Decision Date April 15, 2016
Days to Decision 130 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
5d slower than avg
Panel avg: 125d · This submission: 130d
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 74
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K153501.
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Direxion Torqueable Microcatheter
K142259 · Boston Scientific Corp · Sep 2014
CANTATA(R) 2.9 MICROCATHETER
K131772 · Cook, Inc. · Feb 2014
DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS
K132947 · Boston Scientific Corp · Oct 2013