510(k) · Cleared
ClearedVascular-Access-Port
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 Mar 1, 1983 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Mar 1, 1983
- Review
- 57 days
- Class
- Class II
- Product code
- LJT
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK830000 Vascular-Access-PortNorfolk Medical Products, Inc. · 1983
- Descendant · cites it directly · 6 of its ownK030636 C-PORTClinisurg Vascular Products, LLC · 2003
- Descendant · 2 generations on · 5 of its ownK091099 C-Port - HP Power Injectable PortPhs Medical GmbH · 2009
- Descendant · cites it directly · 3 of its ownK102385 Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK111101 Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
- Descendant · 3 generations on · 1 of its ownK112713 Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K030636C-PORTClinisurg Vascular Products, LLC · 2003 · cites it directly6descendants
- K091099C-Port - HP Power Injectable PortPhs Medical GmbH · 2009 · 2 generations on5descendants
- K102385Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011 · cites it directly3descendants
- K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011 · 2 generations on2descendants
- K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K830000 | Vascular-Access-Port | Norfolk Medical Products, Inc. | 1983 | — |
| +1 | K030636 | C-PORT | Clinisurg Vascular Products, LLC | 2003 | — |
| +2 | K091099 | C-Port - HP Power Injectable Port | Phs Medical GmbH | 2009 | — |
| +1 | K102385 | Norfolk Medical Norport Family of Ports | Norfolk Medical Products, Inc. | 2011 | — |
| +2 | K111101 | Norport CT-PC, Lucent Non-Coring Needel Infusion Set | Norfolk Medical | 2011 | — |
| +3 | K112713 | Norfolk Medical-Sportport-Family of Ports | Norfolk Medical Products, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K030636 (Clinisurg Vascular Products, LLC, 2003) has gone furthest, with 6 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.
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) | — |
https://510kreport.com/device/K830000 · printed Nov 6, 2026
Cite this page
510(k) Report. “K830000: Vascular-Access-Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830000
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026