Cleared Traditional

K161402 - Bullfrog Micro-Infusion Device

K161402 is an FDA 510(k) clearance for Bullfrog Micro-Infusion Device, manufactured by Mercator Medsystems, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K161402 · Mercator Medsystems, Inc. · Cardiovascular device
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Aug 2016
Decision
90d
Days
Class 2
Risk

K161402 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 August 18, 2016 after a review of 90 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

FDA 510(k) Submission Details - K161402

510(k) Number K161402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2016
Decision Date August 18, 2016
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRA Device Classification - Class 2, Special Controls

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 131
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K161402.
VAMP Venous/Arterial Blood Management Protection System
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K160884 · Cook Incorporated · Nov 2016
SwiftNINJA Microcatheter
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CrossCath Support Catheter
K161801 · Cook Incorporated · Jul 2016
Direxion Torqueable Microcatheter
K142259 · Boston Scientific Corp · Sep 2014
RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
K140329 · Boston Scientific · May 2014