510(k) · Cleared
Recalled · 2011Celsite Venous System
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 Jul 21, 1995 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 21, 1995
- Review
- 49 days
- Class
- Class II
- Product code
- LJT
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK952548 Celsite Venous SystemB.Braun Medical, Inc. · 1995
- Descendant · cites it directly · 2 of its ownK993024 Celsite Implantable Port with Valved CatheterB. Braun of America, Inc. · 2000 · Recalled
- Descendant · cites it directly · 2 of its ownK962230 Celsite Port with Preconnected CatheterB.Braun Medical, Inc. · 1996 · Recalled
- 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 4 of 4 · See all- K993024Celsite Implantable Port with Valved CatheterB. Braun of America, Inc. · 2000 · cites it directly2descendants
- K962230Celsite Port with Preconnected CatheterB.Braun Medical, Inc. · 1996 · cites it directly2descendants
- K061424Celsite/ Celsite Concept, Access PortsAesculap, Inc. · 2006 · cites it directly1descendant
- K130576Celsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952548 | Celsite Venous System | B.Braun Medical, Inc. | 1995 | — |
| +1 | K993024 | Celsite Implantable Port with Valved Catheter | B. Braun of America, Inc. | 2000 | 1 |
| +1 | K962230 | Celsite Port with Preconnected Catheter | B.Braun Medical, Inc. | 1996 | 1 |
| +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 |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 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? (4)
4 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… |
| Jun 22, 2009 | Not classified | Z-1961-2009 | Nonconforming Material/Component | B. Braun Interventional Systems was notified by B. Braun Medical France, the manufacturer of the Celsite Access port that they had received 11 reports of polyurethane (type P) catheter disconnections. B. Braun Medical France has decided… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K993024 (B. Braun of America, Inc., 2000) has gone furthest, with 2 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/K952548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K952548: Celsite Venous System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K952548
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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