Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Medtronic, Inc. — Predicate Candidate Screening

211 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

70 daysmedian FDA review time
172 days90th percentile
211clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261335VitalFlow Set with Balance™ BiosurfaceMedtronic, Inc.2026-07-31990
K261866Concerto Versa™ Detachable CoilMedtronic, Inc.2026-06-24200
K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.2026-04-23912
K253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.2026-02-191460
K253998Clearview Intracoronary ShuntsMedtronic, Inc.2026-01-20390
K251831Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc.2026-01-152160
K253511Concerto Versa™ Detachable CoilMedtronic, Inc.2026-01-14700
K253409C320LBB Delivery System (C320LBBS45), C320LBB Delivery SysteMedtronic, Inc.2025-12-19800
K251258MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous CannMedtronic, Inc.2025-06-20580
K250075Medtronic Stedi Extra Support GuidewireMedtronic, Inc.2025-06-131540
K250199VitalFlow ConsoleMedtronic, Inc.2025-05-201171
K250558SelectSite C304 Deflectable Catheter System (C304); C315 DelMedtronic, Inc.2025-03-27300
K242705Streamline Unipolar Pediatric Temporary Pacing Lead (6491) SMedtronic, Inc.2025-01-171300
K243892Affera Integrated Mapping SystemMedtronic, Inc.2025-01-17300
K243435Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc.2024-12-05300
K241828Affera Integrated Mapping System; Impedance Localization PatMedtronic, Inc.2024-11-011300
K240880VitalFlow Set with Balance BiosurfaceMedtronic, Inc.2024-09-121640
K241352Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous ReserMedtronic, Inc.2024-06-12301
K241259Amplatz Goose Neck Snare KitMedtronic, Inc.2024-06-03280
K240534Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc.2024-04-19530
K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.2024-03-28150
K233838Emprint Ablation System with Thermosphere Technology (OveralMedtronic, Inc.2024-03-281150
K233943Affera Mapping System (AFR-00003); Location Reference Patch Medtronic, Inc.2024-03-08850
K231206DLP Silicone Coronary Artery Ostial CannulaeMedtronic, Inc.2023-12-072240
K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.2023-12-06301
K233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.2023-12-02600
K233320LINQ II™ Insertable Cardiac Monitor (LNQ22)Medtronic, Inc.2023-10-31321
K232321FlexCath Contour™ Steerable SheathMedtronic, Inc.2023-10-31890
K230960DLP™ Silicone Coronary Artery Ostial CannulaeMedtronic, Inc.2023-05-04290
K230553LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ Medtronic, Inc.2023-04-26571
K223168Tubing and Accessories Sets for Extracorporeal Membrane OxygMedtronic, Inc.2023-04-191900
K230640Affinity Fusion™ Oxygenator SystemMedtronic, Inc.2023-04-06290
K223630Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable CMedtronic, Inc.2023-04-051210
K223488ClosureFast™ Endovenous Radiofrequency Ablation CatheterMedtronic, Inc.2023-03-231220
K223508Cardioblate Gemini-s 49260 Surgical Ablation Device; CardiobMedtronic, Inc.2022-12-22300
K221962LINQ II Insertable Cardiac MonitorMedtronic, Inc.2022-08-25511
K201057Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc.2022-01-146330
K213631Chocolate PTA Balloon CatheterMedtronic, Inc.2021-12-15280
K212027TurboHawk Plus Directional Atherectomy SystemMedtronic, Inc.2021-08-24562
K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.2021-07-22240
K201100Bio-Medicus Life Support Catheter and IntroducerMedtronic, Inc.2021-07-154470
K203556Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient CablesMedtronic, Inc.2021-07-122170
K210484LINQ II Insertable Cardiac Monitor, Zelda AI ECG ClassificatMedtronic, Inc.2021-06-111120
K211304LINQ II Insertable Cardiac MonitorMedtronic, Inc.2021-05-28291
K211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.2021-05-27480
K192712Attain Select II + SureValve delivery catheter system, AttaiMedtronic, Inc.2020-08-033110
K200795LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, DevMedtronic, Inc.2020-07-03992
K201449SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible AnnulMedtronic, Inc.2020-07-01300
K201118Exacta External Drainage and Monitoring System, Exacta Pole Medtronic, Inc.2020-05-26290
K201068Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Medtronic, Inc.2020-05-21290

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda