Cleared Traditional

K182610 - Valleylab FT10 Electrosurgical Platform

K182610 is the FDA 510(k) clearance for Valleylab FT10 Electrosurgical Platform by Medtronic. It is a Class 2 Cardiovascular device (product code OCL) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K182610 · Medtronic · Cardiovascular device
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Dec 2018
Decision
89d
Days
Class 2
Risk

K182610 is an FDA 510(k) clearance for the Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation De.... Classified as Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue (product code OCL), Class II - Special Controls.

Submitted by Medtronic (Minneapolis, US). The FDA issued a Cleared decision on December 19, 2018 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4400 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic devices

Submission Details

510(k) Number K182610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2018
Decision Date December 19, 2018
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Surgical Device For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
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 - OCL Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue

All 33
Devices cleared under the same product code (OCL) and FDA review panel - the closest regulatory comparables to K182610.
Coolrail Linear Pen
K190587 · AtriCure, Inc. · Jul 2019
Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device
K190623 · Medtronic · May 2019
COBRA Fusion Ablation System
K190151 · AtriCure, Inc. · Feb 2019
Coolrail Linear Pen
K183065 · AtriCure, Inc. · Dec 2018
Isolator Multifunctional Linear Pen
K163408 · AtriCure, Inc. · Jan 2017
ISOLATOR LINEAR PEN
K130521 · AtriCure, Inc. · Apr 2013