Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FOZ · Predicate Candidate Screening
506 FDA 510(k) clearances under this product code; the 50 most recent screened below.
101 daysmedian FDA review time
291 days90th percentile
506clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261041 | ClearSafe Closed System | MedSource Labs, LLC | 2026-07-10 | 101 | 0 |
| K260539 | MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ | MedSource Labs, LLC | 2026-07-09 | 142 | 0 |
| K253235 | Introcan Safety® Deep Access XL IV Catheter | B.Braun Medical, Inc. | 2026-05-15 | 228 | 0 |
| K252137 | BD Insyte™ IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2026-04-02 | 268 | 0 |
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64 | Poly Medicure Limited | 2026-04-01 | 233 | 0 |
| K252398 | SURFLO Hybria Closed System Safety IV Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | 2025-12-17 | 139 | 0 |
| K252677 | Polyshield Safety IV Catheters | Poly Medicure Limited | 2025-11-05 | 72 | 0 |
| K251422 | BD Saf-T-Intima™ Subcutaneous Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-10-08 | 154 | 0 |
| K243403 | BD Nexiva™ Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-07-25 | 267 | 0 |
| K251155 | BD Cathena™ Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-07-11 | 88 | 0 |
| K251654 | BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autog | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-06-27 | 28 | 0 |
| K250682 | BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiv | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-06-03 | 89 | 0 |
| K243105 | Ruby Intravascular Catheter | Venocare, Inc. | 2025-05-16 | 228 | 0 |
| K250292 | OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) | Skydance Vascular, Inc. | 2025-05-02 | 91 | 0 |
| K244059 | HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (7000610 | Access Vascular, Inc. | 2025-03-27 | 86 | 0 |
| K243599 | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2025-03-14 | 113 | 0 |
| K242281 | Arrow Endurance Extended Dwell Peripheral Catheter System (E | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2024-12-20 | 140 | 0 |
| K241115 | SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Cent | Spectrum Vascular | 2024-11-27 | 218 | 0 |
| K240359 | PowerGlide Pro™ Midline Catheter | Becton, Dickinson and Company (Bard Access Systems, Inc.) | 2024-07-29 | 174 | 0 |
| K241845 | Introcan Safety® 2 IV Catheter | B.Braun Medical, Inc. | 2024-07-26 | 30 | 0 |
| K233106 | AccuCath Ace™ Intravascular Catheter | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2024-04-19 | 205 | 0 |
| K232234 | Nouvo Safety Set | Poly Medicure Limited | 2024-03-15 | 232 | 0 |
| K233529 | BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZ | Becton Dickinson Infusion Therapy Systems, Inc. | 2023-12-01 | 29 | 0 |
| K231239 | Nexiva™ Closed IV Catheter System with NearPort™ IV Access | Becton Dickinson Infusion Therapy Systems, Inc. | 2023-09-22 | 147 | 0 |
| K231401 | Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin S | Poly Medicure Limited | 2023-09-21 | 129 | 0 |
| K223788 | The MedSource TrueSafe Blood Control I.V. Safety Catheter, a | Medsource International, LLC | 2023-09-15 | 270 | 0 |
| K231626 | OSPREY Closed IV Catheter System (OspreyV2) | Skydance Vascular, Inc. | 2023-08-31 | 90 | 0 |
| K221827 | Mais Central Venous Catheter | Saudi Mais Co. For Medical Products | 2023-06-23 | 365 | 0 |
| K230616 | Polyguard and Polyshield Safety IV Catheters | Poly Medicure Limited | 2023-05-05 | 60 | 0 |
| K223018 | OSPREY PERIPHERAL IV Catheter System | Skydance Vascular, Inc. | 2023-04-14 | 197 | 0 |
| K223648 | Cook® Spectrum® 2 MRC Central Venous Catheter | Cook Advanced Technologies | 2023-02-03 | 59 | 0 |
| K220772 | HydroMID 4F Single Lumen Midline Catheter | Access Vascular, Inc. | 2022-12-07 | 266 | 0 |
| K210929 | MagiCath II | Woo Young Medical Co., Ltd. | 2022-09-13 | 533 | 0 |
| K212370 | Leaderflex Mini and Leaderflex Nano | Vygon USA | 2022-08-29 | 395 | 0 |
| K220756 | Introcan Safety 2 IV Catheter | B.Braun Medical, Inc. | 2022-06-23 | 100 | 0 |
| K220626 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 2022-05-14 | 71 | 0 |
| K220584 | BD Cathena Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2022-03-31 | 30 | 2 |
| K210037 | Pluski Safe 1 Safety IV Catheter | Mediplus (India) Limited | 2022-03-25 | 443 | 0 |
| K213664 | B. Braun Introcan Safety 2 IV Catheter | B.Braun Medical, Inc. | 2022-02-11 | 81 | 0 |
| K213085 | Introcan Safety 3 Closed IV Catheter | B.Braun Medical, Inc. | 2021-10-25 | 31 | 1 |
| K202060 | Disposable IV catheter | Shinva Ande Healthcare Apparatus Co., Ltd. | 2021-07-23 | 361 | 0 |
| K200891 | BD Intima II Closed IV Catheter System, BD Intima II PLUS Cl | Becton, Dickinson and Company | 2021-06-02 | 425 | 0 |
| K203069 | HydroMID | Access Vascular, Inc. | 2021-02-08 | 122 | 3 |
| K201075 | BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguar | Becton, Dickinson and Company | 2020-12-18 | 240 | 11 |
| K193158 | ACENT™ Central Venous Catheter | Global Medikit Limited | 2020-11-24 | 376 | 0 |
| K201717 | BD Cathena Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2020-09-22 | 91 | 0 |
| K200373 | Deltaven Fast Flash Closed I.V. Catheter Systems | Delta Med Spa | 2020-08-26 | 194 | 0 |
| K193278 | MedSource CathMED IV Catheter | Medsource Labs | 2020-08-07 | 254 | 0 |
| K192230 | MF SAFECATH | Medifirst Co., Ltd. | 2020-04-23 | 251 | 0 |
| K200266 | BD Centro Vena Acute Central Line (7 French Dual Lumen) | Bard Access Systems, Inc. (Bard Has Joined Bd) | 2020-04-07 | 64 | 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