510(k) · Cleared
ClearedSmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AngioDynamics, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on May 22, 2020 as substantially equivalent to K101017 (AngioDynamics, Inc., 2010) and 1 other predicate after a 444-day review. Its family tree reaches back 12 generations to 2000. 2 of the 70 devices in its family, counting itself, have a Class I recall.
- Decided
- May 22, 2020
- Review
- 444 days
- Class
- Class II
- Product code
- LJT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K001901 (2000). 69 ancestors in all, the oldest K830256 (1983). No later device cites it as a predicate yet. 2 of the 70 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations between
- 3 generations backK073210 Modification to: T-Port HP Infusion PortPfm Medical, Inc. · 2007
- 2 generations backK122767 Nmi PortNavilyst Medical, Inc. · 2013 · Recalled
- 1 generation backK131694 Nmi Port II CatheterNavilyst Medical, Inc. · 2013 · Recalled
- This deviceK190559 SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc. · 2020
Show all 12 generations
- Root · 12 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 11 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 10 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 9 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 8 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 7 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 6 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 5 generations backK070003 Power Injectable Implantable Infusion Port with Silicone Lumen…Medcomp · 2007 · Recalled
- 4 generations backK071993 T-Port HP Infusion PortPfm Medical, Inc. · 2007
- 3 generations backK073210 Modification to: T-Port HP Infusion PortPfm Medical, Inc. · 2007
- 2 generations backK122767 Nmi PortNavilyst Medical, Inc. · 2013 · Recalled
- 1 generation backK131694 Nmi Port II CatheterNavilyst Medical, Inc. · 2013 · Recalled
- This deviceK190559 SmartPort+ Implantable Ports, SmartPort Plastic Implantable PortsAngioDynamics, Inc. · 2020
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −11 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −10 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −9 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −8 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −7 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −6 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| −5 | K070003 | Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and… | Medcomp | 2007 | 3 |
| −4 | K071993 | T-Port HP Infusion Port | Pfm Medical, Inc. | 2007 | — |
| −3 | K073210 | Modification to: T-Port HP Infusion Port | Pfm Medical, Inc. | 2007 | — |
| −2 | K122767 | Nmi Port | Navilyst Medical, Inc. | 2013 | 6 |
| −1 | K131694 | Nmi Port II Catheter | Navilyst Medical, Inc. | 2013 | 2 |
| 0 (this device) | K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports | AngioDynamics, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 2 | 1 |
| 1987 | 2 | 0 |
| 1989 | 4 | 0 |
| 1991 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 1 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LJT device
- #1 K251253 PowerPort™ isp Implantable Port; PowerPort™…score 14.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101017 | Angiodynamics, Inc., Smart Port CT Series Port Access SystemsSummary page 4…LJT Regulation number: 880.5965 D.PREDICATE DEVICE(S) 1. 510(k) Number K101017 Trade Name: AngioDynamics Inc. Smart Port CT Series Port Access… | 2010 |
| * | K131694 | Nmi Port II CatheterSummary page 5…880.5965 1 2. 510(k) Number K131694 Trade Name: NMI Port II Common/Usual Name:… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 6 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 7 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 31 of the 69 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All LJT devicesLJT Port & Catheter, Implanted, Subcutaneous, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LJT
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJT
182in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJT
1in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LJT
4,308in 2025
MAUDE reports naming product code LJT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 85 | 1 | 208 |
| 2008 | 7 | 119 | 2 | 161 |
| 2009 | 2 | — | 2 | 172 |
| 2010 | 2 | — | 19 | 207 |
| 2011 | 5 | 144 | 1 | 202 |
| 2012 | 2 | — | 2 | 153 |
| 2013 | 7 | 150 | 0 | 141 |
| 2014 | 2 | — | 0 | 143 |
| 2015 | 4 | 164 | 1 | 149 |
| 2016 | 3 | 182 | 0 | 135 |
| 2017 | 0 | — | 1 | 262 |
| 2018 | 0 | — | 1 | 878 |
| 2019 | 1 | — | 7 | 765 |
| 2020 | 1 | — | 0 | 959 |
| 2021 | 0 | — | 0 | 1,285 |
| 2022 | 0 | — | 1 | 1,334 |
| 2023 | 1 | — | 0 | 1,221 |
| 2024 | 1 | — | 0 | 1,896 |
| 2025 | 2 | — | 0 | 4,308 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The ports are indicated for patients who require long-term access to the central venous system for blood specimen withdrawal and administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products, as well as the administration and adequate removal of nuclear medicine. When used with power injectable needles, the ports are indicated for power injection of contrast media. For power…
Read the full statement (128 words)
The ports are indicated for patients who require long-term access to the central venous system for blood specimen
withdrawal and administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional
therapy and blood products, as well as the administration and adequate removal of nuclear medicine.
When used with power injectable needles, the ports are indicated for power injection of contrast media. For power
injection of contrast media, the maximum recommended infusion rate is 5 mL/s with 19G or 20G non-coring power
injectable needles or 2 mL/s with a 22G non-coring power injectable needle.
Needle Size (G), Catheter Size (F) Maximum Recommended Maximum Recommended
non-coring power injectable Flow Rate Setting (mL/s) Pressure Setting (psi)
19/20 5,6 and 8 5 300
22 5,6 and 8 2 300
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190559: SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190559
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026