Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DYB — Predicate Candidate Screening
706 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
227 days90th percentile
706clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253526 | NAMIC Dilator and Sheath | Medline Industries, LP | 2026-07-29 | 258 | 0 |
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture | Hartman Medical Group, LLC | 2026-07-06 | 59 | 0 |
| K261242 | SimplGuide | Pendracare | 2026-06-25 | 71 | 0 |
| K261950 | Health Line Tearaway Introducer | Health Line International Corporation | 2026-06-22 | 12 | 0 |
| K261492 | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | 2026-06-05 | 30 | 0 |
| K260606 | Echo Large Bore Introducer Sheath | Echo Medical, LLC | 2026-04-29 | 64 | 0 |
| K254248 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | 2026-04-23 | 115 | 0 |
| K254279 | Edwards eSheath+ introducer set | Edwards Lifesciences | 2026-04-17 | 108 | 0 |
| K260091 | Aventus Introducer Sheath | Inquis Medical | 2026-04-13 | 91 | 0 |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. | 2026-04-10 | 28 | 0 |
| K260942 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2026-04-07 | 18 | 0 |
| K260459 | VANES Delivery System (VDS) | Zoll Respicardia, Inc. | 2026-04-06 | 54 | 0 |
| K260626 | Multiflex Steerable Sheath 17.5F | Vizaramed, Inc. | 2026-03-26 | 28 | 0 |
| K260163 | AuST CSP Introducer | CenterPoint Systems, LLC | 2026-02-19 | 30 | 0 |
| K254236 | Peel-Away Introducer Sheath | VascuTech Medical, LLC | 2026-02-09 | 42 | 0 |
| K253652 | Genie MAX Large Bore Introducer Sheath | Cultiv8 1, LLC | 2026-01-22 | 63 | 0 |
| K252508 | Intri26 Introducer Sheath | Inari Medical, Inc. | 2025-12-17 | 131 | 0 |
| K253741 | V•Stick™ Vascular Access Set | Argon Medical Devices, Inc. | 2025-12-15 | 21 | 0 |
| K252309 | PerQseal Introducers | Vivasure Medical Limited | 2025-10-23 | 91 | 0 |
| K251838 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | 2025-10-21 | 127 | 0 |
| K252766 | 14Fr Low Profile Introducer Kit | Abiomed, Inc. | 2025-10-08 | 40 | 0 |
| K252441 | Primero Safe Access System | South53, LLC | 2025-09-29 | 56 | 0 |
| K252227 | Pounce(TM) Sheath | Surmodics,Inc. | 2025-09-24 | 70 | 0 |
| K252027 | Vertex(TM) Catheter | Jupiter Endovascular | 2025-09-12 | 74 | 0 |
| K252364 | Edwards eSheath Optima introducer set | Edwards Lifesciences | 2025-08-29 | 31 | 0 |
| K251051 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2025-04-30 | 27 | 0 |
| K250909 | Prelude Wave Hydrophilic Sheath Introducer | Merit Medical Systems, Inc. | 2025-04-25 | 30 | 0 |
| K243954 | PeriCross™ Epicardial Access Kit | Circa Scientific, Inc. | 2025-04-24 | 122 | 0 |
| K244046 | Edwards eSheath Optima introducer set | Edwards Lifesciences | 2025-03-27 | 87 | 0 |
| K250468 | iSLEEVE Introducer Set | Boston Scientific | 2025-03-20 | 30 | 0 |
| K243928 | ViaOne Epicardial Access System | Cardiovia , Ltd. | 2025-03-20 | 90 | 0 |
| K250439 | Catapult Guide Sheath; 4F; 15cm (US-34015-F-ST-H); Catapult | Contract Medical International, GmbH | 2025-03-16 | 30 | 0 |
| K243493 | Agilis NxT Steerable Introducer Dual-Reach | ABBOTT MEDICAL | 2024-12-13 | 31 | 0 |
| K242520 | Element Vascular Access System | Penumbra, Inc. | 2024-11-20 | 89 | 0 |
| K242756 | Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, | Pulnovo Medical (Wuxi) Co., Ltd. | 2024-11-08 | 57 | 0 |
| K243061 | SonoStik Guide Wire Introducer | Sonostik, LLC | 2024-11-04 | 38 | 0 |
| K242106 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024-10-04 | 78 | 0 |
| K241230 | Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1 | Togo Medikit Co., Ltd. | 2024-09-17 | 138 | 0 |
| K240600 | SafeCross Vascular Introducer System (4001) | East End Medical I, LLC | 2024-09-06 | 186 | 0 |
| K242169 | Morph DNA Steerable Introducer Sheath | Biocardia | 2024-08-23 | 30 | 0 |
| K242248 | Introducer Sheath Kits | Beijing Demax Medical Technology Co.,Ltd | 2024-08-22 | 22 | 0 |
| K240957 | Catapult Guide Sheath | Contract Medical International, GmbH | 2024-08-14 | 128 | 0 |
| K241708 | Abiomed 14Fr Low Profile Introducer Kit | Abiomed, Inc. | 2024-08-06 | 54 | 4 |
| K241145 | TLAB® Transvenous Liver Biopsy System (TF-18C) | Argon Medical Devices, Inc. | 2024-08-01 | 98 | 0 |
| K241370 | Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED) | ABBOTT MEDICAL | 2024-06-13 | 30 | 0 |
| K240829 | AuST Steerable Sheath | CenterPoint Systems, LLC | 2024-05-01 | 36 | 0 |
| K240589 | Micropuncture Introducer Sets; Micropuncture Pedal Access Se | Cook Medical | 2024-03-25 | 24 | 0 |
| K233708 | NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S | Synaptic Medical Corporation | 2024-02-16 | 88 | 0 |
| K233959 | EPi-Ease Epicardial Access Device (EAS) | AtriCure, Inc. | 2024-02-13 | 60 | 0 |
| K240004 | CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); C | Circa Scientific, Inc. | 2024-01-31 | 29 | 0 |
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