Cleared Traditional

K252116 - Firefighter™ Pro PTCA Balloon Catheter (FDA 510(k) Clearance)

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

K252116 · Shanghai MicroPort Medical (Group) Co., Ltd. · Cardiovascular device
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Apr 2026
Decision
274d
Days
Class 2
Risk

K252116 is an FDA 510(k) clearance for the Firefighter™ Pro PTCA Balloon Catheter. Classified as Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX), Class II - Special Controls.

Submitted by Shanghai MicroPort Medical (Group) Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on April 7, 2026 after a review of 274 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5100 - 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 Shanghai MicroPort Medical (Group) Co., Ltd. devices

Submission Details

510(k) Number K252116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2025
Decision Date April 07, 2026
Days to Decision 274 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
149d slower than avg
Panel avg: 125d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5100
Definition A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End.
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 - LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

All 85
Devices cleared under the same product code (LOX) and FDA review panel - the closest regulatory comparables to K252116.
FLASH Flex™ Aorto-Ostial Angioplasty System
K254022 · Verge Medical, Inc. · Apr 2026
Ryurei
K252295 · Terumo Corporation · Mar 2026
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
K251970 · Medtronic, Ireland · Jan 2026
Pantera Pro
K242969 · Biotronik, Inc. · Oct 2024
Sapphire NC ULTRA Coronary Dilatation Catheter
K233499 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Aug 2024
Sapphire ULTRA Coronary Dilatation Catheter
K233505 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Aug 2024