510(k) · Cleared
ClearedCelsite (TM) Implantable Drug Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Burron Medical, Inc. · FMF Syringe, Piston
Cleared on Oct 8, 1991 after a 496-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Oct 8, 1991
- Review
- 496 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK902401 Celsite (TM) Implantable Drug Delivery SystemBurron Medical, Inc. · 1991
- Descendant · cites it directly · 3 of its ownK952435 Celsite Pediatric Venous SystemB.Braun Medical, Inc. · 1996 · Recalled
- Descendant · 2 generations on · 1 of its ownK110424 Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached…Medcomp ( Medical Components) · 2011
- Descendant · cites it directly · 1 of its ownK061424 Celsite/ Celsite Concept, Access PortsAesculap, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 0 of its ownK130576 Celsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc. · 2013 · Recalled
- Descendant · 3 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 5 of 5 · See all- K952435Celsite Pediatric Venous SystemB.Braun Medical, Inc. · 1996 · cites it directly3descendants
- K110424Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached; Dignity Low Profile…Medcomp ( Medical Components) · 2011 · 2 generations on1descendant
- K061424Celsite/ Celsite Concept, Access PortsAesculap, Inc. · 2006 · cites it directly1descendant
- K130576Celsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc. · 2013 · 2 generations on0descendants
- K121383PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components)Medical Components, Inc. · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K902401 | Celsite (TM) Implantable Drug Delivery System | Burron Medical, Inc. | 1991 | — |
| +1 | K952435 | Celsite Pediatric Venous System | B.Braun Medical, Inc. | 1996 | 1 |
| +2 | K110424 | Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached; Dignity Low… | Medcomp ( Medical Components) | 2011 | — |
| +1 | K061424 | Celsite/ Celsite Concept, Access Ports | Aesculap, Inc. | 2006 | 2 |
| +2 | K130576 | Celsite Implantable Access Port Systems | B. Braun Interventional Systems, Inc. | 2013 | 2 |
| +3 | K121383 | PS X Series (Basic Components and Catheter), PD X Series (Catheter with All… | Medical Components, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 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? (5)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K952435 (B.Braun Medical, Inc., 1996) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
https://510kreport.com/device/K902401 · printed Nov 5, 2026
Cite this page
510(k) Report. “K902401: Celsite (TM) Implantable Drug Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K902401
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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