510(k) · Cleared
ClearedCatheter Innovations Implantable Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Catheter Innovations, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Dec 3, 1999 as substantially equivalent to K991897 (Catheter Innovations, Inc., 1999) and 2 other predicates after an 18-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Dec 3, 1999
- Review
- 18 days
- Class
- Class II
- Product code
- LJT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K873213 (1987). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K873213 | Hickman Plastic Subcutaneous Port | C.R. Bard, Inc. | 1987 | 3 |
| −1 | K991897 | Catheter Innovations Implantable Port | Catheter Innovations, Inc. | 1999 | 9 |
| 0 (this device) | K993860 | Catheter Innovations Implantable Port | Catheter Innovations, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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? (3)
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 |
|---|---|---|---|
| * | K991897 | Catheter Innovations Implantable PortSummary page 1…e on 510(k) Submissions for Implanted Infusion Ports” by the CORH, ODE, Division of Gastroenterology/Urology and General Use Devices (October 1990) Predicate Device(s): K 991897 — Catheter Innovations, Inc. Single and Dual-Lumen implantable Ports (Approved to Market - October 21, 1999) K880571 — Originall… | 1999 |
| * | K880571 | Cath-Tech Port Implantable Vascular Access SystemSummary page 1…l Use Devices (October 1990) Predicate Device(s): K 991897 — Catheter Innovations, Inc. Single and Dual-Lumen implantable Ports (Approved to Market - October 21, 1999) K880571 — Originally submitted as Catheter Technologies Port Implantable Vascular Access System (Approved to Market - March 4, 1988) — C… | 1988 |
| * | K873213 | Hickman Plastic Subcutaneous PortSummary page 1…lantable Vascular Access System (Approved to Market - March 4, 1988) — Currently marketed by Bard Access Systems as “BardPort™ Implanted Ports with Groshong® catheters” K873213 — Hickman® Subcutaneous Port currently marketed by Bard Access Systems Description of Device Modification: Traditionally, impla… | 1987 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 2 companies; a new generation was cleared every 12.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
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) | — |
What is it indicated for?
The Catheter Innovations Implantable Port is designed for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993860 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993860: Catheter Innovations Implantable Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993860
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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