510(k) · Cleared
Recalled · 2011Celsite Port with Preconnected Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Dec 16, 1996 as substantially equivalent to K952548 (B.Braun Medical, Inc., 1995) after a 189-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it. It has been recalled once.
- Decided
- Dec 16, 1996
- Review
- 189 days
- Class
- Class II
- Product code
- LJT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952548 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK952548 Celsite Venous SystemB.Braun Medical, Inc. · 1995 · Recalled
- This deviceK962230 Celsite Port with Preconnected CatheterB.Braun Medical, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK061424 Celsite/ Celsite Concept, Access PortsAesculap, Inc. · 2006 · Recalled
- Descendant · cites it directly · 0 of its ownK130576 Celsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc. · 2013 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952548 | Celsite Venous System | B.Braun Medical, Inc. | 1995 | 2 |
| 0 (this device) | K962230 | Celsite Port with Preconnected Catheter | B.Braun Medical, Inc. | 1996 | — |
| +1 | K061424 | Celsite/ Celsite Concept, Access Ports | Aesculap, Inc. | 2006 | 2 |
| +1 | K130576 | Celsite Implantable Access Port Systems | B. Braun Interventional Systems, Inc. | 2013 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K952548 | Celsite Venous SystemSummary page 1…ION NAME: General Hospital Devices Class (III1/ 80 LJT Implafiféd Port & Catheter, Intravascular, Infusion SUBSTANTIAL EQUIVALENCE! TO: 510(k) number Name Applicant K952548 CELSITE™ Venous B. Braun Medical Access System DEVICE DESCRIPTION: The Celsite™ Port with Preconnected Catheter is an implanted… | 1995 |
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 13, 2011 | Not classified | Z-2671-2011 | Process design | The affected products contain the incorrect winged Surecan needle accessory component in certain Celsite Access Port package configurations. The winged Surecan needle is used to deliver medications and fluids into implanted Celsite Access… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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/K962230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962230: Celsite Port with Preconnected Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962230
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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