Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LJS — Predicate Candidate Screening
302 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
291 days90th percentile
302clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260929 | Neonav ECG Tip Location System | Navi Medical Technologies | 2026-04-17 | 28 | 0 |
| K252373 | BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Tec | Spectrum Vascular | 2025-12-16 | 139 | 0 |
| K252792 | PM2™ System with ECGuide™ Connector | Piccolo Medical, Inc. | 2025-11-17 | 76 | 0 |
| K243458 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire | Access Vascular, Inc. | 2025-08-01 | 266 | 0 |
| K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); | Access Vascular, Inc. | 2025-07-01 | 74 | 0 |
| K243484 | PM2+ System and SmartPICC Stylet | Piccolo Medical, Inc. | 2025-05-29 | 202 | 0 |
| K241587 | pilot TLS | Vygon Corporation | 2025-02-26 | 268 | 0 |
| K241910 | Neonav ECG Tip Location System | Navi Medical Technologies | 2025-01-19 | 202 | 0 |
| K243941 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire | Access Vascular, Inc. | 2025-01-17 | 28 | 0 |
| K240486 | PM2 System and ECGuide Connector | Piccolo Medical, Inc. | 2024-09-08 | 201 | 0 |
| K233149 | CATHTONG III Tapered PICC Catheter | L&Z Us, Inc. | 2023-12-01 | 65 | 0 |
| K230669 | L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Cat | Argon Medical Devices | 2023-11-30 | 265 | 3 |
| K232571 | CATHTONG™ II PICC Catheter | L&Z Us, Inc. | 2023-09-22 | 29 | 0 |
| K232594 | CATHTONG™ II PICC Catheter | L&Z Us, Inc. | 2023-09-22 | 28 | 0 |
| K222232 | Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Ass | Bard Access Systems, Inc. | 2022-08-24 | 30 | 0 |
| K220363 | VPS Rhythm DLX Device with TipTracker Technology | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2022-08-22 | 195 | 0 |
| K213550 | HydroPICC 5F Dual Lumen Catheter | Access Vascular, Inc. | 2022-05-04 | 177 | 2 |
| K210264 | BD PowerPiCC Catheter | Bard Access Systems, Inc. | 2021-07-30 | 179 | 2 |
| K201452 | Groshong NXT PICC Catheter | C.R. Bard, Inc. | 2021-03-12 | 284 | 1 |
| K200037 | Piccolo Medical SmartPICC System | Piccolo Medical, Inc. | 2021-01-22 | 380 | 0 |
| K192246 | Biowy PICC Catheter S Kit | Biowy Corporation | 2020-04-30 | 255 | 0 |
| K193015 | HydroPICC (PICC-142) | Access Vascular, Inc. | 2020-02-20 | 114 | 4 |
| K180546 | Jet Power Injectable PICC | Jet Medical, Inc. | 2018-11-21 | 265 | 0 |
| K181904 | 5 FR Dual Lumen Piper PICC | Piper Access, LLC | 2018-09-25 | 71 | 0 |
| K180560 | Sherlock 3CG+ T ip Confirmation System | C.R. Bard, Inc. | 2018-06-18 | 109 | 0 |
| K173956 | Biowy PlCC Catheter | Biowy Corporation | 2018-05-21 | 144 | 0 |
| K180548 | 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherer | C.R. Bard, Inc (Bard Has Joined Bd) | 2018-04-26 | 56 | 1 |
| K172511 | Hickman TriFusion Catheter | C.R. Bard, Inc. | 2018-04-20 | 242 | 0 |
| K180567 | C3 Wave System | Medical Components, Inc. (dba MedComp) | 2018-04-12 | 38 | 0 |
| K172899 | Vygon PICCs | Vygon USA | 2018-02-26 | 157 | 0 |
| K171994 | Silicone Peripherally Inserted Central Venous Catheter Set/T | Cook Incorporated | 2018-02-22 | 234 | 0 |
| K172885 | HydroPICC | Access Vascular, Inc. | 2018-02-20 | 152 | 0 |
| K170934 | C3 Wave System | Medical Components, Inc (Dba Medcomp_ | 2017-12-06 | 251 | 0 |
| K171931 | Celerity ECG Cable Accessory Pack | Medcomp (Medical Components, Inc.) | 2017-10-26 | 120 | 0 |
| K172397 | Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2017-09-29 | 52 | 0 |
| K172039 | CATHTONG II PICC Catheter | L&Z Us, Inc. | 2017-08-03 | 29 | 0 |
| K170486 | CATHTONG II PICC Catheter | L&Z Us, Inc. | 2017-05-25 | 101 | 0 |
| K162441 | PowerPICC Provena Catheters with SOLO Valve Technology | C.R. Bard, Inc. | 2017-04-24 | 236 | 0 |
| K163452 | PICC Maximal Barrier Nursing Kit | Navilyst Medical, Inc. | 2017-02-03 | 56 | 0 |
| K160925 | VPS Rhythm Device with TipTracker Technology | Arrow International, Inc. (A Subsidiary of Teleflex, Inc.) | 2016-12-22 | 262 | 1 |
| K162443 | PowerPICC Provena Catheters | C.R. Bard, Inc. | 2016-10-25 | 55 | 1 |
| K161496 | Turbo-Flo PICC Sets | Cook Incorporated | 2016-10-07 | 128 | 0 |
| K161765 | CG+ Arrow JACC | Arrow International, Inc. (Subsidiary of Teleflex | 2016-09-06 | 71 | 0 |
| K153469 | Cathtong I PICC Catheter | L&Z Us, Inc. | 2016-09-01 | 275 | 0 |
| K151985 | PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter | C.R. Bard, Inc. | 2016-06-14 | 333 | 0 |
| K152819 | Amecath Peripheral inserted Central Venous Catheter Sets | Ameco Medical Industries | 2016-02-05 | 130 | 0 |
| K153487 | CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VP | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016-02-04 | 62 | 1 |
| K153423 | CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016-01-28 | 64 | 1 |
| K152261 | PICC Tip Positioning Aid | Nostix, LLC | 2015-10-21 | 71 | 0 |
| K152409 | Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Pow | Navilyst Medical, Inc. | 2015-09-24 | 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