Cleared Traditional

K210339 - Bullfrog Micro-Infusion Device (FDA 510(k) Clearance)

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

K210339 · Mercator Medsystems, Inc. · Cardiovascular device
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Aug 2021
Decision
178d
Days
Class 2
Risk

K210339 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 2, 2021 after a review of 178 days - an extended review 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: 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 K210339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2021
Decision Date August 02, 2021
Days to Decision 178 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
53d slower than avg
Panel avg: 125d · This submission: 178d
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 172
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K210339.
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