510(k) · Cleared
ClearedNorport CT-PC, Lucent Non-Coring Needel Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Norfolk Medical · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Aug 25, 2011 as substantially equivalent to K102385 (Norfolk Medical Products, Inc., 2011) and 8 other predicates after a 127-day review. Its family tree reaches back 11 generations to 2000. 2 later devices descend from it.
- Decided
- Aug 25, 2011
- Review
- 127 days
- Class
- Class II
- Product code
- LJT
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 11 generations to K001901 (2000). 60 ancestors in all, the oldest K830000 (1983). 2 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations between
- 3 generations backK072375 Smartport CT MP Port Access System and Lifeguard CT Safety Infusion…AngioDynamics, Inc. · 2007
- 2 generations backK081472 Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium…AngioDynamics, Inc. · 2008 · Recalled
- 1 generation backK102385 Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011
- This deviceK111101 Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
- Descendant · cites it directly · 1 of its ownK112713 Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK192291 TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020
Show all 11 generations
- Root · 11 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 10 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 9 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 8 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 7 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 6 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 5 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 4 generations backK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
- 3 generations backK072375 Smartport CT MP Port Access System and Lifeguard CT Safety Infusion…AngioDynamics, Inc. · 2007
- 2 generations backK081472 Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium…AngioDynamics, Inc. · 2008 · Recalled
- 1 generation backK102385 Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011
- This deviceK111101 Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −10 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −9 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −8 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −7 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −6 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −5 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| −4 | K062414 | Vortex CT Port Access System and Lifeguard Safety Infusion Set | Rita Medical Systems, Inc. | 2007 | 2 |
| −3 | K072375 | Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set | AngioDynamics, Inc. | 2007 | — |
| −2 | K081472 | Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low… | AngioDynamics, Inc. | 2008 | 1 |
| −1 | K102385 | Norfolk Medical Norport Family of Ports | Norfolk Medical Products, Inc. | 2011 | — |
| 0 (this device) | K111101 | Norport CT-PC, Lucent Non-Coring Needel Infusion Set | Norfolk Medical | 2011 | — |
| +1 | K112713 | Norfolk Medical-Sportport-Family of Ports | Norfolk Medical Products, Inc. | 2011 | — |
| +2 | K192291 | TidalPort-AP Implantable Apheresis Vascular Access Port | Norfolk Medical Products, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 5 | 0 |
| 1988 | 1 | 0 |
| 1989 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2020 | 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.
Planning a device in LJT? 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? (9)
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 |
|---|---|---|---|
| * | K102385 | Norfolk Medical Norport Family of PortsSummary page 3…rvoir with an attachable catheter system. The Port reservoir consists of a titanium or polysulfone chamber with a silicone septum and an outlet pin (5 10 (k)4102385). The silicone septum is designed to allow multiple needle puncturing while maintaining the leak-tight integrity.… | 2011 |
| * | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleSummary page 2…5 10 (k)# 1023 85, 2010 Device Name: Bard Power Port Titanium Port w/8Fr Premarket Notification: 5 10 (k)# 060812, 2006 Device Name: Smiths Medical PORT-A-CATH Titanium… | 2006 |
| * | K070116 | Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Summary page 2…Smiths Medical PORT-A-CATH Titanium Venous Access System Premarket Notification: 510 (k)# 070116, 2007 Device Name: Angiodynamics Smartport CT Series Port… | 2007 |
| * | K081472 | Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile…Summary page 2…Angiodynamics Smartport CT Series Port Access System Premarket Notification: 5 10 (k)# 081472, 2008 Device Name: PBS C-PortHP "Power Injectable" Port Premarket Notification:… | 2008 |
| * | K091099 | C-Port - HP Power Injectable PortSummary page 2…5 10 (k)# 081472, 2008 Device Name: PBS C-PortHP "Power Injectable" Port Premarket Notification: 5 10 (k)# 091099, 2009 Device Name: MEDCOMP ProFUSE CT Premarket Notification: 510 (k)# 070003… | 2009 |
| * | K070003 | Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…Summary page 2…t Notification: 5 10 (k)# 091099, 2009 Device Name: MEDCOMP ProFUSE CT Premarket Notification: 510 (k)# 070003, 2007 12 Norfolk #Medica1 7350… | 2007 |
| * | K072375 | Smartport CT MP Port Access System and Lifeguard CT Safety Infusion SetSummary page 3…Angiodynamics Lifeguard CT Safety Infusion Set Premarket Notification: 5 10 (k)# 072375, 2007 Device Name: Bard PowerLoc Clear Safety Infusion Set Premarket Notification:… | 2007 |
| * | K082306 | Powerloc Clear Safety Infusion SetSummary page 3…5 10 (k)# 072375, 2007 Device Name: Bard PowerLoc Clear Safety Infusion Set Premarket Notification: 510 (k)# 082306, 2008 Device Name: MEDCOMP CT Injectable Safety Huber… | 2008 |
| * | K080544 | UnassignedSummary page 3…ame: MEDCOMP CT Injectable Safety Huber Needle Premarket Notification: 5 10 (k)# 080544, 2008 5.4 Device Description NorPort CT-PC Port Family of Implanted Vascular Access Devices: The Norfolk M… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112713 | Norfolk Medical-Sportport-Family of Ports | 2011 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 27 of the 60 ancestors have a recall of any class.
- Of its descendants, K112713 (Norfolk Medical Products, Inc., 2011) has gone furthest, with 1 descendant of its own.
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. 2011, 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 Lucent Non-coring needle set is intended for the administration of fluids and drugs as well as blood sampling through implanted vascular ports. When used with the NorPort CT-PC Family of Implanted Vascular Access Device is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, the maximum recommended infusion rate is 5 mI/s with a 19 and 20 gauge non-coring power injectable needle…
Read the full statement (186 words)
The Lucent Non-coring needle set is intended for the administration of fluids and drugs as well as blood sampling through implanted vascular ports.
When used with the NorPort CT-PC Family of Implanted Vascular Access Device is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, the maximum recommended infusion rate is 5 mI/s with a 19 and 20 gauge non-coring power injectable needle and 2 mI/s with a 22-gauge non-coring power injectable needle.
The NorPort CT-PC Family of Implanted Vascular Access Devices is indicated for use when the patient requires the following: repeated access to the vascular system for injections, infusion of drugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen.
When used with a appropriately labeled power injectable needle infusion set, the NorPort CT-PC Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mI/s with a 19 and 20 gauge non-coring power injectable needle and 2 mI/s with a 22-gauge non-coring power injectable needle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111101: Norport CT-PC, Lucent Non-Coring Needel Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111101
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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