Cleared Traditional

K182610 - Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device

K182610 is an FDA 510(k) clearance for Valleylab FT10 Electrosurgical Platform, manufactured by Medtronic. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K182610

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.

OCL Device Classification - Class 2, Special Controls

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 43
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
EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
K142084 · Ncontact Surgical, Inc. · Oct 2014