Cleared Traditional

K212625 - PathBuilder Transseptal Needle (FDA 510(k) Clearance)

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

K212625 · Shanghai Microport EP Medtech Co., Ltd. · Cardiovascular device
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Mar 2022
Decision
217d
Days
Class 2
Risk

K212625 is an FDA 510(k) clearance for the PathBuilder Transseptal Needle. Classified as Trocar (product code DRC), Class II - Special Controls.

Submitted by Shanghai Microport EP Medtech Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on March 23, 2022 after a review of 217 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1390 - 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 EP Medtech Co., Ltd. devices

Submission Details

510(k) Number K212625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2021
Decision Date March 23, 2022
Days to Decision 217 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
92d slower than avg
Panel avg: 125d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRC Trocar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1390
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 - DRC Trocar

All 50
Devices cleared under the same product code (DRC) and FDA review panel - the closest regulatory comparables to K212625.
Accusafe Transseptal Guidewire (GTR31180, GTR31230)
K240246 · Synaptic Medical Corporation · Jul 2024
SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
K241042 · Pressure Products Medical Device Manufacturing, LLC · May 2024
SafeSept® Transseptal Guidewire (SS-140)
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K210328 · Pressure Products Medical Device Manufacturing, LLC · Mar 2021