510(k) Report

510(k) · Cleared

Cleared

C-PORT

K030636510(k) TraditionalCleared Jun 5, 200397-day reviewClass II21 CFR 880.5965

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Clinisurg Vascular Products, LLC · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on Jun 5, 2003 as substantially equivalent to K830000 (Norfolk Medical Products, Inc., 1983) after a 97-day review. Its family tree reaches back 1 generation to 1983. 6 later devices descend from it.

Decided
Jun 5, 2003
Review
97 days
Class
Class II
Product code
LJT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K830000 (1983). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2011: 3 descendants cleared2012: 1 descendant cleared2020: 1 descendant clearedK830000 · Vascular-Access-Port · Norfolk Medical Products, Inc. · 198319801990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K830000 · Vascular-Access-Port · Norfolk Medical Products, Inc. · 19830
  1. Root · 1 generation backK830000 Vascular-Access-PortNorfolk Medical Products, Inc. · 1983
  2. This deviceK030636 C-PORTClinisurg Vascular Products, LLC · 2003
  3. Descendant · cites it directly · 5 of its ownK091099 C-Port - HP Power Injectable PortPhs Medical GmbH · 2009
  4. Descendant · 2 generations on · 3 of its ownK102385 Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011
  5. Descendant · 2 generations on · 2 of its ownK111101 Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
  6. Descendant · 3 generations on · 1 of its ownK112713 Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011
  7. Descendant · 4 generations on · 0 of its ownK192291 TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2009: 12011: 32012: 12020: 1
2009high 3 (2011) · low 0 (2010)2026

Most influential descendants

Showing 5 of 6 · See all
  • K091099C-Port - HP Power Injectable PortPhs Medical GmbH · 2009 · cites it directly5descendants
  • K102385Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011 · 2 generations on3descendants
  • 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
  • K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K830000Vascular-Access-PortNorfolk Medical Products, Inc.1983—
0 (this device)K030636C-PORTClinisurg Vascular Products, LLC2003—
+1K091099C-Port - HP Power Injectable PortPhs Medical GmbH2009—
+2K102385Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc.2011—
+2K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical2011—
+3K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc.2011—
+4K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201130
201210
202010
FIG. 1 — Lineage of K030636, 1983–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251253 PowerPort™ isp Implantable Port; PowerPort™…score 14.9 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K830000Vascular-Access-Port
Summary page 2
…ing device(s): 0 Titan Port or Vortex Port, from Norfolk Medical Products, now Horizon Medical Products since November 1998 (#K830000 - 1983). 13. Type of medical device: The CliniSurg family of Vascular Access devices is…
Norfolk Medical Products, Inc.1983—

Also cleared against K830000: 1 other device →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091099C-Port - HP Power Injectable PortPhs Medical GmbH20095

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?

  • Its one ancestor has no recall.
  • Of its descendants, K091099 (Phs Medical GmbH, 2009) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K830000.

How does its category compare?

All LJT devices

LJT Port & Catheter, Implanted, Subcutaneous, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJT

2in 2025

2007: 112008: 72009: 22010: 22011: 52012: 22013: 72014: 22015: 42016: 32019: 12020: 12023: 12024: 12025: 22026 (partial year): 1
2007high 11 (2007) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJT

182in 2016

2007: 85 days median2008: 119 days median2011: 144 days median2013: 150 days median2015: 164 days median2016: 182 days median
2007high 182 (2016) · low 85 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LJT

1in 2022

2007: 12008: 22009: 22010: 192011: 12012: 22015: 12017: 12018: 12019: 72022: 12026 (partial year): 1, 1 Class I
2007high 19 (2010) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · LJT

4,308in 2025

2007: 2082008: 1612009: 1722010: 2072011: 2022012: 1532013: 1412014: 1432015: 1492016: 1352017: 2622018: 8782019: 7652020: 9592021: 1,2852022: 1,3342023: 1,2212024: 1,8962025: 4,308
2007high 4,308 (2025) · low 135 (2016)2025

MAUDE reports naming product code LJT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200711851208
200871192161
20092—2172
20102—19207
201151441202
20122—2153
201371500141
20142—0143
201541641149
201631820135
20170—1262
20180—1878
20191—7765
20201—0959
20210—01,285
20220—11,334
20231—01,221
20241—01,896
20252—04,308
20261—1 (1)—

What is it indicated for?

The C-Port family of products will be used as a subcutaneously implanted device where repeated access to the vascular system is the therapy of choice for delivery of medications, fluids, nutritional solutions and blood products or withdrawal of blood.

Indications for use as stated in the FDA summary.

Also cleared against K830000

1 other device cites the same predicate.

  • K102385Norfolk Medical Norport Family of PortsNorfolk Medical Products, Inc. · 2011

Recent decisions in LJT

The LJT category page

  • K260916FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc. · 2026
  • K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port…Bard Access Systems, Inc. · 2025
  • K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port…Bard Access Systems, Inc. · 2025
  • K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsBard Access Systems, Inc. · 2024
  • K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable…Bard Peripheral Vascular, Inc. · 2023

https://510kreport.com/device/K030636 · printed Nov 4, 2026

Cite this page

510(k) Report. “K030636: C-PORT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030636

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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