510(k) · Cleared
ClearedNorfolk Medical-Sportport-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 Oct 27, 2011 as substantially equivalent to K111101 (Norfolk Medical, 2011) after a 38-day review. Its family tree reaches back 12 generations to 2000. 1 later device descends from it.
- Decided
- Oct 27, 2011
- Review
- 38 days
- Class
- Class II
- Product code
- LJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K001901 (2000). 61 ancestors in all, the oldest K830000 (1983). 1 later device descends from it, 1 citing it directly.
- 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 backK081472 Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium…AngioDynamics, Inc. · 2008 · Recalled
- 2 generations backK102385 Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011
- 1 generation backK111101 Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
- This deviceK112713 Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK192291 TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, 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 backK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
- 4 generations backK072375 Smartport CT MP Port Access System and Lifeguard CT Safety Infusion…AngioDynamics, Inc. · 2007
- 3 generations backK081472 Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium…AngioDynamics, Inc. · 2008 · Recalled
- 2 generations backK102385 Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011
- 1 generation backK111101 Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
- This deviceK112713 Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020 · cites it directly0descendants
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 | K062414 | Vortex CT Port Access System and Lifeguard Safety Infusion Set | Rita Medical Systems, Inc. | 2007 | 2 |
| −4 | K072375 | Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set | AngioDynamics, Inc. | 2007 | — |
| −3 | K081472 | Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low… | AngioDynamics, Inc. | 2008 | 1 |
| −2 | 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 | — |
| 0 (this device) | K112713 | Norfolk Medical-Sportport-Family of Ports | Norfolk Medical Products, Inc. | 2011 | — |
| +1 | 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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K111101 | Norport CT-PC, Lucent Non-Coring Needel Infusion Set | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192291 | TidalPort-AP Implantable Apheresis Vascular Access Port | 2020 | 0 |
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 61 ancestors have a recall of any class.
- Of its descendants, K192291 (Norfolk Medical Products, Inc., 2020) has gone furthest, with 0 descendants 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 SportPort TM is indicated for use when the patient requires the following: repeated access to the vascular system for injections, infusion of dmugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen.
When used with a power injectable needle infusion set, the SportPortTM 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 or 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/K112713 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112713: Norfolk Medical-Sportport-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/K112713
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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