510(k) · Cleared
ClearedNorfolk Medical Norport Family of Ports
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Norfolk Medical Products, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Jan 14, 2011 as substantially equivalent to K091099 (Phs Medical GmbH, 2009) and 7 other predicates after a 144-day review. Its family tree reaches back 10 generations to 2000. 3 later devices descend from it.
- Decided
- Jan 14, 2011
- Review
- 144 days
- Class
- Class II
- Product code
- LJT
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 10 generations to K001901 (2000). 44 ancestors in all, the oldest K830000 (1983). 3 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 6 generations between
- 3 generations backK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
- 2 generations backK072375 Smartport CT MP Port Access System and Lifeguard CT Safety Infusion…AngioDynamics, Inc. · 2007
- 1 generation backK081472 Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium…AngioDynamics, Inc. · 2008 · Recalled
- This deviceK102385 Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK111101 Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
- Descendant · 2 generations on · 1 of its ownK112713 Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK192291 TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020
Show all 10 generations
- Root · 10 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 9 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 8 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 7 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 6 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 5 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 4 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 3 generations backK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
- 2 generations backK072375 Smartport CT MP Port Access System and Lifeguard CT Safety Infusion…AngioDynamics, Inc. · 2007
- 1 generation backK081472 Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium…AngioDynamics, Inc. · 2008 · Recalled
- This deviceK102385 Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011
Most influential descendants
Showing 3 of 3 · See all- K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011 · cites it directly2descendants
- K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011 · 2 generations on1descendant
- K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −9 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −8 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −7 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −6 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −5 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −4 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| −3 | K062414 | Vortex CT Port Access System and Lifeguard Safety Infusion Set | Rita Medical Systems, Inc. | 2007 | 2 |
| −2 | K072375 | Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set | AngioDynamics, Inc. | 2007 | — |
| −1 | K081472 | Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low… | AngioDynamics, Inc. | 2008 | 1 |
| 0 (this device) | K102385 | Norfolk Medical Norport Family of Ports | Norfolk Medical Products, Inc. | 2011 | — |
| +1 | K111101 | Norport CT-PC, Lucent Non-Coring Needel Infusion Set | Norfolk Medical | 2011 | — |
| +2 | K112713 | Norfolk Medical-Sportport-Family of Ports | Norfolk Medical Products, Inc. | 2011 | — |
| +3 | 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 | 4 | 0 |
| 1989 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 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? (8)
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 |
|---|---|---|---|
| * | K091099 | C-Port - HP Power Injectable PortSummary page 9…=== Norfolk #Medical 7350 N. Ridgeway, Skokie, IL 60076 * 847-674-7075 predicates: Norfolk Medical Vascular Access Port (K830000), the PHS C-Port (K091099), the Angiodynamics Vortex VX Port Implantable Infusion Podt (KOS81472), and the Bard PowerPort Implanted Titanium Podt Chronofle… | 2009 |
| * | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleSummary page 9…S C-Port (K091099), the Angiodynamics Vortex VX Port Implantable Infusion Podt (KOS81472), and the Bard PowerPort Implanted Titanium Podt Chronoflex with 8 Fr. Catheter (K060812). DEPARTMENT OF HEALTH &,HUMAN SERVICES Public Health Service… | 2006 |
| * | K081472 | Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile…Summary page 2…ication: 510 (k)# 060812, 2006 Device Name: Angiodynaniycs Vortex® Premarket Notification: 5 10 (k)# 081472, 2008 Device Name: Vascular Medical Access Port, NorPorC' Premarket Notification:… | 2008 |
| * | K830000 | Vascular-Access-PortSummary page 9…ir respective Norfolk #Medical 7350 N. Ridgeway, Skokie, IL 60076 * 847-674-7075 predicates: Norfolk Medical Vascular Access Port (K830000), the PHS C-Port (K091099), the Angiodynamics Vortex VX Port Implantable Infusion Podt (KOS81472), and the Bard PowerPort Implant… | 1983 |
| * | K871192 | Subcutaneously Implanted Drug Delivery DepotSummary page 2…5 10 (k)# 830000, 1983 Device Name: Norfolk Medical, material Titanium Premarket Notification: 510 (k)# 871192, 1987 Device Name: Norfolk Medical, change to silicone… | 1987 |
| * | K871209 | Norfolk Medical NorportSummary page 2…Norfolk Medical, change to silicone catheter. Premarket Notification: 5 10 (k)# 871209, 1987 Device Name: Norfolk Medical, change to silicone septum. Premarket Notification:… | 1987 |
| * | K863723 | Norfolk Norport/Subcutan. Implanted Drug DepotSummary page 2…5 10 (k)# 871209, 1987 Device Name: Norfolk Medical, change to silicone septum. Premarket Notification: 510 (k)# 863723, 1986 Device Name: Norfolk Medical, material polysulfone. Premarket Notification:… | 1986 |
| * | K840788 | Vascular Access Port Changes in MaterSummary page 2…510 (k)# 863723, 1986 Device Name: Norfolk Medical, material polysulfone. Premarket Notification: 510 (k)# 840788, 1984 5.4 Device Description Our device is composed of a port reservoir with an attachable catheter system. The… | 1984 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111101 | Norport CT-PC, Lucent Non-Coring Needel Infusion Set | 2011 | 2 |
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 5 companies; a new generation was cleared every 10 months on median.
- 22 of the 44 ancestors have a recall of any class.
- Of its descendants, K111101 (Norfolk Medical, 2011) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K091099.
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 NorPort Family of Implanted Vascular Access Devices is indicated for use when the patient requires repeated access to the vascular system for injections, infusion dmugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102385: Norfolk Medical Norport Family of Ports.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102385
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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