510(k) · Cleared
Recalled · Class II · 2025Celsite Pediatric 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 Apr 17, 1996 as substantially equivalent to K902401 (Burron Medical, Inc., 1991) and 1 other predicate after a 329-day review. Its family tree reaches back 1 generation to 1991. 3 later devices descend from it. It has been recalled once.
- Decided
- Apr 17, 1996
- Review
- 329 days
- Class
- Class II
- Product code
- LJT
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K902401 (1991). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK902401 Celsite (TM) Implantable Drug Delivery SystemBurron Medical, Inc. · 1991
- This deviceK952435 Celsite Pediatric Venous SystemB.Braun Medical, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK110424 Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached…Medcomp ( Medical Components) · 2011
- Descendant · cites it directly · 0 of its ownK130576 Celsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK121383 PS X Series (Basic Components and Catheter), PD X Series (Catheter…Medical Components, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See all- K110424Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached; Dignity Low Profile…Medcomp ( Medical Components) · 2011 · cites it directly1descendant
- K130576Celsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc. · 2013 · cites it directly0descendants
- K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902401 | Celsite (TM) Implantable Drug Delivery System | Burron Medical, Inc. | 1991 | — |
| 0 (this device) | K952435 | Celsite Pediatric Venous System | B.Braun Medical, Inc. | 1996 | — |
| +1 | K110424 | Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached; Dignity Low… | Medcomp ( Medical Components) | 2011 | — |
| +1 | K130576 | Celsite Implantable Access Port Systems | B. Braun Interventional Systems, Inc. | 2013 | 2 |
| +2 | K121383 | PS X Series (Basic Components and Catheter), PD X Series (Catheter with All… | Medical Components, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 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? (2)
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 |
|---|---|---|---|
| * | K902401 | Celsite (TM) Implantable Drug Delivery SystemSummary page 1…FICATION NAME: General Hospital Devices Class Ill, 80 LJT, Implanted Port & Catheter, Intravascular, Infusion SUBSTANTIAL EQUIVALENCE' TO: 510(k) number Name Applicant K902401 CELSITE™ Implantable Burron Medical Inc. Drug Delivery System (previous title of B. Braun Medical Inc.) K942024 PORT-A-CATH LOW P… | 1991 |
| * | K942024 | Port-a-Cath Low Profile Implantable Venous Access SystemSummary page 1…UBSTANTIAL EQUIVALENCE' TO: 510(k) number Name Applicant K902401 CELSITE™ Implantable Burron Medical Inc. Drug Delivery System (previous title of B. Braun Medical Inc.) K942024 PORT-A-CATH LOW PHARMACIA DELTEC PROFILE IMPLANTABLE INC. VENOUS ACCESS DEVICE DESCRIPTION: The CELSITE® Pediatric Venous Port… | 1994 |
What descends from it? (3)
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 |
|---|---|---|---|---|
| Jul 21, 2025 | Class II | Z-2528-2025 | Under Investigation by firm | The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall. |
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/K952435 · printed Nov 5, 2026
Cite this page
510(k) Report. “K952435: Celsite Pediatric Venous System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952435
Report an extraction error
Are you the manufacturer?
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