Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Becton Dickinson Infusion Therapy Systems, Inc. · Predicate Candidate Screening
36 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
183 days90th percentile
36clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252137 | BD Insyte™ IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2026-04-02 | 268 | 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 |
| K241586 | PIVO™ Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-02-27 | 269 | 0 |
| K233529 | BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZ | Becton Dickinson Infusion Therapy Systems, Inc. | 2023-12-01 | 29 | 0 |
| K230865 | PIVO™ Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | 2023-09-28 | 183 | 0 |
| K231239 | Nexiva™ Closed IV Catheter System with NearPort™ IV Access | Becton Dickinson Infusion Therapy Systems, Inc. | 2023-09-22 | 147 | 0 |
| K220584 | BD Cathena Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2022-03-31 | 30 | 2 |
| K201717 | BD Cathena Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2020-09-22 | 91 | 0 |
| K192493 | BD Cathena (TM) Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2020-01-24 | 135 | 0 |
| K183399 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2019-03-20 | 103 | 1 |
| K173354 | BD Nexiva Diffusics Closed IV Catheter Systems | Becton Dickinson Infusion Therapy Systems, Inc. | 2017-12-15 | 51 | 0 |
| K161777 | BD Nexiva and BD Nexiva Diffusics Closed IV Catheter Systems | Becton Dickinson Infusion Therapy Systems, Inc. | 2016-08-29 | 61 | 0 |
| K151698 | BD Angiocath IV Catheter, BD Insyte IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2015-07-27 | 33 | 0 |
| K143610 | BD INTIMA II CLOSED IV CATHETER | Becton Dickinson Infusion Therapy Systems, Inc. | 2015-04-09 | 111 | 0 |
| K123734 | BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM | Becton Dickinson Infusion Therapy Systems, Inc. | 2013-01-17 | 43 | 0 |
| K102520 | BD NEXIVA CLOSED IV CATHETER SYSTEM | Becton Dickinson Infusion Therapy Systems, Inc. | 2011-01-06 | 126 | 0 |
| K100775 | BD INTIMA II CLOSED IV CATHETER | Becton Dickinson Infusion Therapy Systems, Inc. | 2010-06-03 | 77 | 0 |
| K050207 | BD POSIFLOW POSITIVE DISPLACEMENT VALVE | Becton Dickinson Infusion Therapy Systems, Inc. | 2005-04-07 | 69 | 0 |
| K042862 | BD ONECATH | Becton Dickinson Infusion Therapy Systems, Inc. | 2004-12-03 | 49 | 0 |
| K032843 | NEXIVA CLOSED IV CATHETER SYSTEM | Becton Dickinson Infusion Therapy Systems, Inc. | 2004-02-27 | 169 | 16 |
| K020834 | BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION | Becton Dickinson Infusion Therapy Systems, Inc. | 2002-06-12 | 90 | 0 |
| K013621 | BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 | Becton Dickinson Infusion Therapy Systems, Inc. | 2002-04-16 | 162 | 11 |
| K013304 | BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SH | Becton Dickinson Infusion Therapy Systems, Inc. | 2002-01-02 | 90 | 0 |
| K013800 | INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AU | Becton Dickinson Infusion Therapy Systems, Inc. | 2001-12-21 | 36 | 0 |
| K013073 | INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AU | Becton Dickinson Infusion Therapy Systems, Inc. | 2001-11-08 | 55 | 0 |
| K002033 | BD INSYTE AUTOGUARD -P AND BD INSYTE AUTOGUARD -P WINGED IV | Becton Dickinson Infusion Therapy Systems, Inc. | 2000-07-26 | 21 | 0 |
| K000235 | INSYTE CATHETER, INSYTE AUTOGUARD CATHETER | Becton Dickinson Infusion Therapy Systems, Inc. | 2000-04-05 | 69 | 0 |
| K974764 | INTROSYTE CATHETER | Becton Dickinson Infusion Therapy Systems, Inc. | 1998-02-26 | 69 | 2 |
| K972263 | FIRST PICC CATHETER WITH DUAL LUMENS | Becton Dickinson Infusion Therapy Systems, Inc. | 1997-09-15 | 90 | 0 |
| K972264 | FIRST MIDCATH CATHETER | Becton Dickinson Infusion Therapy Systems, Inc. | 1997-09-15 | 90 | 0 |
| K972262 | FIRST PICC CATHETER | Becton Dickinson Infusion Therapy Systems, Inc. | 1997-09-15 | 90 | 0 |
| K972254 | FIRST MIDCATH CATHETER | Becton Dickinson Infusion Therapy Systems, Inc. | 1997-09-12 | 88 | 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