Cleared Traditional

K200514 - Cardioblate Gemini-s Surgical Ablation Device

K200514 is an FDA 510(k) clearance for Cardioblate Gemini-s Surgical Ablation ..., manufactured by Medtronic. The device is a Class 2 Cardiovascular device with product code OCL cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K200514 · Medtronic · Cardiovascular device
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Jun 2020
Decision
93d
Days
Class 2
Risk

K200514 is an FDA 510(k) clearance for the Cardioblate Gemini-s Surgical Ablation Device. 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 June 3, 2020 after a review of 93 days - within the typical 510(k) review window.

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: 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 Medtronic devices

FDA 510(k) Submission Details - K200514

510(k) Number K200514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2020
Decision Date June 03, 2020
Days to Decision 93 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
32d faster than avg
Panel avg: 125d · This submission: 93d
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 K200514.
Cardioblate Gemini-s 49260 Surgical Ablation Device
K223508 · Medtronic, Inc. · Dec 2022
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
K210477 · AtriCure, Inc. · Jul 2021
AtriCure Isolator® Synergy™ Surgical Ablation System
K211311 · AtriCure, Inc. · May 2021
EPi-Sense Guided Coagulation System with VisiTrax
K193162 · AtriCure, Inc. · Dec 2019
Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
K192125 · AtriCure, Inc. · Nov 2019
Cardioblate CryoFlex Surgical Ablation System
K191526 · Medtronic, Inc. · Oct 2019