Atlas FDA

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

NRY — Predicate Candidate Screening

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

122 daysmedian FDA review time
257 days90th percentile
110clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.2026-07-161950
K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.2026-06-104600
K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou Zenith Vascular SciTech Limited2026-05-202660
K254276Lynx Aspiration Catheter SystemQ’Apel Medical, Inc.2026-05-071280
K253590Millipede SystemPerfuze, Ltd.2026-03-161190
K253062Tigertriever 25 Revascularization DeviceRapid Medical Ltd.2026-03-121710
K251357Esperance pHLO Aspiration SystemPhenox, Ltd.2026-01-152600
K251006NeVasc Aspiration SystemVesalio, Inc.2025-11-102230
K252046Zoom System (Zoom 4S Catheter)Imperative Care, Inc.2025-10-301220
K251603Tigertriever 17 Ultra Revascularization DeviceRapid Medical Ltd.2025-10-061320
K251789EMBOTRAP III Revascularization DeviceNeuravi Limited2025-09-251060
K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.2025-08-29290
K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SeCerenovus, Inc.2025-08-22700
K243948Raptor Aspiration Catheter; Balt Aspiration Tubing SetBalt USA, LLC2025-06-031620
K243047Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD AspiratioImperative Care, Inc.2025-05-282430
K243601Route 92 Medical HiPoint Reperfusion System and Aspiration TRoute 92 Medical, Inc.2025-05-191790
K251015APRO 45 Catheter and Alembic Aspiration TubingAlembic, LLC2025-04-30280
K250958APRO 55 Swift Catheter and Alembic Aspiration TubingAlembic, LLC2025-04-28280
K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SPerfuze, Ltd.2025-02-26550
K243287APRO 70 Swift Catheter and Alembic Aspiration TubingAlembic, LLC2025-02-241290
K242104Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc.2025-02-132100
K242672Zoom SystemImperative Care, Inc.2025-01-141300
K243080Riptide Aspiration SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular2024-10-29290
K241221CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 IntermediatCerenovus, Inc.2024-10-161680
K240917Esperance 3+ Aspiration Catheter SystemWallaby Medical2024-10-011810
K242504Millipede 088 Access Catheter; Millipede 070 Aspiration CathPerfuze, Ltd.2024-09-20290
K234083Next Generation Aspiration Catheter; Balt Aspiration Tubing Balt USA, LLC2024-07-021930
K233329Route 92 Medical Full Length 054 Reperfusion System and AspiRoute 92 Medical, Inc.2024-04-232070
K232971APRO 55 Catheter and Alembic Aspiration TubingAlembic, LLC2024-02-291610
K233988Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing SCerenovus, Inc.2024-01-17300
K232524Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SPerfuze, Ltd.2023-10-18610
K223913Socrates Aspiration SystemScientia Vascular, Inc.2023-09-202651
K222786072 Aspiration SystemQ'Apel Medical, Inc.2023-08-253441
K230429Tigertriever 21 Revascularization Device, Tigertriever 17 ReRapid Medical Ltd.2023-04-17590
K223530Route 92 Medical Full Length 070 Reperfusion System and AspiRoute 92 Medical, Inc.2023-04-111391
K230695APRO 70 Catheter and Alembic Aspiration TubingAlembic, LLC2023-04-10280
K221934CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration TubCerenovus, Inc.2023-03-092510
K223545APRO 70 Catheter and Alembic Aspiration TubingAlembic, LLC2023-02-17840
K222808Penumbra System (Reperfusion Catheter RED 43)Penumbra, Inc.2022-12-20950
K220808Tigertriever 13 Revascularization DeviceRapid Medical Ltd.2022-07-251290
K211120ERIC Retrieval DeviceMicroVention, Inc.2022-03-313501
K211697Esperance Aspiration Catheter SystemWallaby Medical2021-11-161660
K212908EmboTrap II Revascularization Device, EMBOTRAP III RevasculaNeuravi, Ltd.2021-10-13300
K211654Penumbra System (Reperfusion Catheter RED 72)Penumbra, Inc.2021-08-16800
K211338EMBOTRAP III Revascularization DeviceNeuravi, Ltd.2021-07-30880
K211411Penumbra System (RED 68 Reperfusion Catheter)Penumbra, Inc.2021-07-01561
K211476ZOOM 71 Reperfusion Catheter; ZOOM Aspiration TubingImperative Care, Inc.2021-06-08270
K203440Penumbra System (Reperfusion Catheter RED 62)Penumbra, Inc.2021-05-201780
K210996ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM AspirationImperative Care, Inc.2021-04-23211
K203592Tigertriever and Tigertriever 17 Revascularization DevceRapid Medical Ltd.2021-03-231050

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