Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

MCW — Predicate Candidate Screening

146 FDA 510(k) clearances under this product code; the 50 most recent screened below.

79 daysmedian FDA review time
224 days90th percentile
146clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260244Auryon Atherectomy SystemEximo Medical2026-04-10730
K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H60Cardio Flow Inc.,2025-04-25460
K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics2025-03-13300
K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.2025-01-301401
K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,2024-11-05410
K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy CathetEximo Medical, Ltd.2024-06-27271
K233483FreedomFlow Orbital Circumferential Atherectomy System (H600Cardio Flow Inc.,2024-02-151110
K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (Eximo Medical, Ltd.2023-12-15300
K231538FreedomFlow Orbital Circumferential Atherectomy SystemCardio Flow Inc.,2023-09-271200
K230709Auryon Atherectomy SystemEximo Medical, Ltd.2023-06-09870
K230005Pantheris LV Atherectomy CatheterAvinger, Inc.2023-06-061540
K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-PowerSpectranetics, Inc.2022-12-08790
K220116Auryon Atherectomy CathetersEximo Medical, Ltd.2022-09-262550
K220962ROTAPRO Rotational Atherectomy SystemBoston Scientific Corporation2022-09-061580
K221077Auryon Atherectomy SystemEximo Medical, Ltd.2022-06-09580
K220568Diamondback 360 Peripheral Orbital Atherectomy System, StealCardiovascualr Systems, Inc.2022-04-27580
K220109DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMOCardiovascular Systems, Inc.2022-03-01470
K212351Revolution Peripheral Atherectomy SystemRex Medical, L.P.2021-12-151390
K212047Pantheris SystemAvinger, Inc.2021-11-161390
K211738Rotarex Atherectomy SystemC.R. Bard, Inc.2021-09-14991
K210586Diamonback 360 Peripheral Orbital Atherectomy System, DiamonCardiovascular Systems, Inc.2021-09-142000
K212027TurboHawk Plus Directional Atherectomy SystemMedtronic, Inc.2021-08-24562
K2115182.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm XVolcano Atheromed, Inc.2021-06-14280
K202835Auryon Atherectomy SystemEximo Medical, Ltd.2020-12-02680
K203008DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMOCardiovascular Systems, Inc.2020-11-19490
K191419Revolution Peripheral Atherectomy System, Revolution PeripheRex Medical, L.P.2019-09-121070
K190634Diamondback 360 Peripheral Orbital Atherectomy System, StealCardiovascular Systems, Inc.2019-07-021120
K182341Pantheris SVAvinger, Inc.2019-04-092240
K182972Phoenix Atherectomy SystemVolcano Atheromed, Inc.2018-12-20550
K181877Phoenix 2.4mm Atherectomy Plus SystemVolcano Atheromed, Inc.2018-12-171570
K182397Diamondback 360 Peripheral Orbital Atherectomy System ExchanCardiovascular Systems, Inc.2018-12-131000
K181642B-Laser Atherectomy SystemEximo Medical, Ltd.2018-10-051060
K173862Pantheris SystemAvinger, Inc.2018-05-221530
K180416ViperWire Advance Guide Wire, Stealth 360 Orbital PeripheralCardiovascular Systems, Inc.2018-04-17610
K172315Straub Endovascular SystemStraub Medical AG2018-04-122541
K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-PowerSpectranetics, Inc.2018-04-05200
K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-PowerSpectranetics, Inc.2017-11-27820
K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HAvinger, Inc.2017-10-30970
K1723861.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm PhoeVolcano Atheromed, Inc.2017-08-24160
K170191SilverHawk Peripheral Plaque Excision System, TurboHawk PeriMedtronic Vascular, Inc.2017-06-161440
K170792Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.2017-06-09850
K170059Spectranetics Turbo-Elite Laser Atherectomy CathetersSpectranetics, Inc.2017-04-07913
K162561Turbo-Power (2.0mm) Laser Atherectomy CathetersSpectranetics, Inc.2017-01-051130
K163264Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Avinger, Inc.2016-12-21300
K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SlAvinger, Inc.2016-10-18600
K161361HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc.2016-10-141512
K160827Pantheris CatheterAvinger, Inc.2016-04-21270
K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc.2016-03-01910
K152181Turbo-Power Laser Atherectomy CatheterSpectranetics, Inc.2015-11-121001
K152694Diamondback 360 Peripheral Orbital Atherectomy SystemCardiovascular Systems, Inc.2015-10-21301

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