Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LJT — Predicate Candidate Screening
288 FDA 510(k) clearances under this product code; the 50 most recent screened below.
96 daysmedian FDA review time
286 days90th percentile
288clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260916 | FLEXI-PORT™ Power Injectable Implantable Port | Portal Access, Inc. | 2026-06-17 | 90 | 0 |
| K252478 | Vaccess™ CT Low-Profile Power-Injectable Implantable Port; V | Bard Access Systems, Inc. | 2025-09-05 | 29 | 0 |
| K251253 | PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable | Bard Access Systems, Inc. | 2025-06-18 | 56 | 0 |
| K242328 | PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ C | Bard Access Systems, Inc. | 2024-10-31 | 86 | 0 |
| K232737 | PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; Powe | Bard Peripheral Vascular, Inc. | 2023-12-08 | 92 | 0 |
| K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable | AngioDynamics, Inc. | 2020-05-22 | 444 | 0 |
| K181446 | Bard Power-Injectable Implantable Ports (PowerPorts®) | C.R. Bard, Inc. | 2019-07-08 | 402 | 0 |
| K151239 | NMI DUAL PORT II | Navilyst Medical, Inc. | 2016-06-06 | 392 | 0 |
| K153359 | BardPort®, SlimPort®, and X-Port® Implanted Ports | C.R. Bard, Inc. | 2016-05-20 | 182 | 0 |
| K153238 | Dignity Dual Port | Medcomp ( Medical Components) | 2016-03-15 | 127 | 0 |
| K153228 | NMI Port, NMI Port II | Navilyst Medical, Inc. | 2015-12-04 | 28 | 0 |
| K150514 | Power-Injectable Implantable Ports with ChronoFlex Polyureth | C.R. Bard, Inc. | 2015-11-20 | 266 | 0 |
| K150733 | Vital-Port Vascular Access System Power Injectable Port | Cook Incorporated | 2015-05-21 | 62 | 0 |
| K141146 | INVISIPORT | Stealth Therapeutics, Incorporated | 2015-05-01 | 361 | 0 |
| K140169 | VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM | Cook Incorporated | 2014-05-21 | 118 | 0 |
| K133335 | POWERPORT IMPLANTABLE PORT | C.R. Bard, Inc. | 2014-02-14 | 108 | 0 |
| K132177 | MEDCOMP GEN III POWER INJECTABLE PORT | Medcomp ( Medical Components) | 2013-12-12 | 150 | 2 |
| K122834 | POLYSITE IMPLANTABLE INFUSION PORTS | Perouse Medical | 2013-12-11 | 450 | 0 |
| K131694 | NMI PORT II CATHETER | Navilyst Medical, Inc. | 2013-08-08 | 59 | 1 |
| K130923 | 5F DIGNITY CT TITANIUM PORT | Medical Components, Inc. | 2013-07-31 | 119 | 0 |
| K122402 | LPP (LOW PROFILE PORT) | Pfm Medical, Inc. | 2013-07-16 | 343 | 0 |
| K122767 | NMI PORT | Navilyst Medical, Inc. | 2013-04-30 | 232 | 1 |
| K130576 | CELSITE IMPLANTABLE ACCESS PORT SYSTEMS | B. Braun Interventional Systems, Inc. | 2013-04-02 | 28 | 2 |
| K122899 | POWERPORT CLEARVUE SLIM IMPLANTABLE PORT | C.R. Bard, Inc. | 2012-11-15 | 55 | 0 |
| K120281 | DIGNITY POWER INJECTABLE TITANIUM PORT | Medical Components, Inc. | 2012-09-17 | 230 | 0 |
| K110424 | DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACH | Medcomp ( Medical Components) | 2011-11-30 | 289 | 0 |
| K112713 | NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS | Norfolk Medical Products, Inc. | 2011-10-27 | 38 | 0 |
| K110407 | INVISIPORT | Stealth Therapeutics, Incorporated | 2011-10-13 | 241 | 0 |
| K111101 | NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SET | Norfolk Medical | 2011-08-25 | 127 | 0 |
| K102385 | NORFOLK MEDICAL NORPORT FAMILY OF PORTS | Norfolk Medical Products, Inc. | 2011-01-14 | 144 | 0 |
| K101017 | ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEM | AngioDynamics, Inc. | 2010-06-17 | 66 | 0 |
| K093414 | PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS | Smiths Medical Asd, Inc. | 2010-03-01 | 119 | 1 |
| K091099 | C-PORT - HP POWER INJECTABLE PORT | Phs Medical GmbH | 2009-05-22 | 36 | 0 |
| K090512 | POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN | C.R. Bard, Inc. | 2009-03-27 | 29 | 0 |
| K082126 | RHAPSODY MRI | Grantadler Corporation | 2008-11-13 | 107 | 0 |
| K081889 | RHAPSODY CT | Grantadler Corporation | 2008-11-12 | 133 | 0 |
| K081425 | COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER I | Cook Vascular, Inc. | 2008-09-30 | 132 | 0 |
| K081472 | SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TIT | AngioDynamics, Inc. | 2008-09-23 | 119 | 1 |
| K081311 | POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER | C.R. Bard, Inc. | 2008-06-04 | 26 | 0 |
| K080645 | STD MED PRIMO PORT POLY | Std Med, Inc. | 2008-05-02 | 57 | 0 |
| K072481 | JET PORT PLUS HP CATHETER SYSTEM | Pfm Medical, Inc. | 2008-03-07 | 185 | 0 |
| K073423 | MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER | C.R. Bard, Inc. | 2007-12-19 | 14 | 0 |
| K072657 | POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. | Smiths Medical MD, Inc. | 2007-12-14 | 85 | 0 |
| K073210 | MODIFICATION TO: T-PORT HP INFUSION PORT | Pfm Medical, Inc. | 2007-12-12 | 28 | 0 |
| K072549 | TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX P | C.R. Bard, Inc. | 2007-11-14 | 65 | 1 |
| K072215 | TITANIUM POWERPORT ISP IMPLANTED PORT | C.R. Bard, Inc. | 2007-11-01 | 84 | 0 |
| K071993 | T-PORT HP INFUSION PORT | Pfm Medical, Inc. | 2007-10-17 | 89 | 0 |
| K070911 | STD MED PRIMO PORT | Std Med, Inc. | 2007-08-10 | 130 | 0 |
| K070116 | POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENO | Smiths Medical MD, Inc. | 2007-05-23 | 131 | 0 |
| K070003 | POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUM | Medcomp | 2007-05-15 | 132 | 3 |
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