510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

Celsite Implantable Access Port Systems

K130576510(k) SpecialCleared Apr 2, 201328-day reviewClass II21 CFR 880.5965Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

B. Braun Interventional Systems, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on Apr 2, 2013 as substantially equivalent to K061424 (Aesculap, Inc., 2006) and 7 other predicates after a 28-day review. Its family tree reaches back 3 generations to 1995. It has been recalled 2 times.

Decided
Apr 2, 2013
Review
28 days
Class
Class II
Product code
LJT
Recalls
2
Predicates
8

Its longest line of descent runs back 3 generations to K952548 (1995). 18 ancestors in all, the oldest K830730 (1983). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 2 other ancestors1996: 1 other ancestor1995: 4 other ancestors2003: 1 other ancestor1999: 1 other ancestor1994: 3 other ancestors1991: 1 other ancestor2001: 1 other ancestor1983: 1 other ancestorK952548 · Celsite Venous System · B.Braun Medical, Inc. · 1995 · recalledK962230 · Celsite Port with Preconnected Catheter · B.Braun Medical, Inc. · 1996 · recalledK061424 · Celsite/ Celsite Concept, Access Ports · Aesculap, Inc. · 2006 · recalled19801985199019952000200520102015
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 6 other ancestors3 generations back: 4 other ancestors K061424 · Celsite/ Celsite Concept, Access Ports · Aesculap, Inc. · 2006 · recalledK962230 · Celsite Port with Preconnected Catheter · B.Braun Medical, Inc. · 1996 · recalledK952548 · Celsite Venous System · B.Braun Medical, Inc. · 1995 · recalled0
  1. Root · 3 generations backK952548 Celsite Venous SystemB.Braun Medical, Inc. · 1995 · Recalled
  2. 2 generations backK962230 Celsite Port with Preconnected CatheterB.Braun Medical, Inc. · 1996 · Recalled
  3. 1 generation backK061424 Celsite/ Celsite Concept, Access PortsAesculap, Inc. · 2006 · Recalled
  4. This deviceK130576 Celsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K952548Celsite Venous SystemB.Braun Medical, Inc.19952
−2K962230Celsite Port with Preconnected CatheterB.Braun Medical, Inc.19961
−1K061424Celsite/ Celsite Concept, Access PortsAesculap, Inc.20062
0 (this device)K130576Celsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199110
199430
199540
199610
199910
200020
200110
200310
FIG. 1 — Lineage of K130576, 1995–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251253 PowerPort™ isp Implantable Port; PowerPort™…score 14.9 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K061424Celsite/ Celsite Concept, Access Ports
Summary page 1
…ation Class 11per 21 CER 880.5965 (Product Code: LiT) Predicate Devices Celsite Implantable Access Port Systems (K061424, K993024, K9941 11, K962230, K952548, K952435, K945752, K945551) Device Description The Celsite®…
Aesculap, Inc.20062
*K993024Celsite Implantable Port with Valved Catheter
Summary page 1
…Class 11per 21 CER 880.5965 (Product Code: LiT) Predicate Devices Celsite Implantable Access Port Systems (K061424, K993024, K9941 11, K962230, K952548, K952435, K945752, K945551) Device Description The Celsite® Implantab…
B. Braun of America, Inc.20001
*K994111Celsite, Models ST401L, ST405L
Summary page 1
…Class 11per 21 CER 880.5965 (Product Code: LiT) Predicate Devices Celsite Implantable Access Port Systems (K061424, K993024, K9941 11, K962230, K952548, K952435, K945752, K945551) Device Description The Celsite® Implantable Access…
B. Braun/Mcgaw2000—
*K962230Celsite Port with Preconnected Catheter
Summary page 1
…11per 21 CER 880.5965 (Product Code: LiT) Predicate Devices Celsite Implantable Access Port Systems (K061424, K993024, K9941 11, K962230, K952548, K952435, K945752, K945551) Device Description The Celsite® Implantable Access Port Syst…
B.Braun Medical, Inc.19961
*K952548Celsite Venous System
Summary page 1
…CER 880.5965 (Product Code: LiT) Predicate Devices Celsite Implantable Access Port Systems (K061424, K993024, K9941 11, K962230, K952548, K952435, K945752, K945551) Device Description The Celsite® Implantable Access Port Systems (Cels…
B.Braun Medical, Inc.19952
*K952435Celsite Pediatric Venous System
Summary page 1
…5965 (Product Code: LiT) Predicate Devices Celsite Implantable Access Port Systems (K061424, K993024, K9941 11, K962230, K952548, K952435, K945752, K945551) Device Description The Celsite® Implantable Access Port Systems (Celsite port…
B.Braun Medical, Inc.19961
*K945752Celsite (TM) Brachial Venous Port
Summary page 1
…ices Celsite Implantable Access Port Systems (K061424, K993024, K9941 11, K962230, K952548, K952435, K945752, K945551) Device Description The Celsite® Implantable Access Port Systems (Celsite port systems) are implantable port and cath…
B. Braun of America, Inc.1995—
*K945551Celsite (TM) Dual Venous System
Summary page 1
…Celsite Implantable Access Port Systems (K061424, K993024, K9941 11, K962230, K952548, K952435, K945752, K945551) Device Description The Celsite® Implantable Access Port Systems (Celsite port systems) are implantable port and catheter syst…
B. Braun of America, Inc.1995—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 21, 2025Class IIZ-2528-2025Under Investigation by firmThe potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
Jun 16, 2015Class IIZ-2382-2015Unknown/Undetermined by firmThe manufacturer, B. Braun medical France, received endotoxin test results that are out of specification for the peelable sheath (A1537).

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
  • 11 of the 18 ancestors have a recall of any class.

How does its category compare?

All LJT devices

LJT Port & Catheter, Implanted, Subcutaneous, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · LJT

2in 2025

2007: 112008: 72009: 22010: 22011: 52012: 22013: 72014: 22015: 42016: 32019: 12020: 12023: 12024: 12025: 22026 (partial year): 1
2007high 11 (2007) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJT

182in 2016

2007: 85 days median2008: 119 days median2011: 144 days median2013: 150 days median2015: 164 days median2016: 182 days median
2007high 182 (2016) · low 85 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LJT

1in 2022

2007: 12008: 22009: 22010: 192011: 12012: 22015: 12017: 12018: 12019: 72022: 12026 (partial year): 1, 1 Class I
2007high 19 (2010) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · LJT

4,308in 2025

2007: 2082008: 1612009: 1722010: 2072011: 2022012: 1532013: 1412014: 1432015: 1492016: 1352017: 2622018: 8782019: 7652020: 9592021: 1,2852022: 1,3342023: 1,2212024: 1,8962025: 4,308
2007high 4,308 (2025) · low 135 (2016)2025

MAUDE reports naming product code LJT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200711851208
200871192161
20092—2172
20102—19207
201151441202
20122—2153
201371500141
20142—0143
201541641149
201631820135
20170—1262
20180—1878
20191—7765
20201—0959
20210—01,285
20220—11,334
20231—01,221
20241—01,896
20252—04,308
20261—1 (1)—

What is it indicated for?

Celsite Access Ports are indicated for patient therapies requiring repeated access to the vascular system.

Celsite / Celsite Concept Access Ports are indicated for intra-venous administration of drugs for chemotherapy, antibiotics and anti-viral drugs, and for parenteral nutrition, blood sampling or transfusions.

Celsite Discreet / Celsite Dual Venous / Celsite Brachial / Celsite Babyport / Celsite Babyport S Ports are recommended for use whenever patient therapy requires repeated I.V. Access for injection, drug therapy and/or blood sampling.

Indications for use as stated in the FDA summary.

More from B. Braun Interventional Systems, Inc.

3 FDA decisions under this applicant name. See the company

  • K162625SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon CathetersB. Braun Interventional Systems, Inc. · 2017
  • K152765Venatech Convertible Vena Cava Filter SystemB. Braun Interventional Systems, Inc. · 2016

Recent decisions in LJT

The LJT category page

  • K260916FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc. · 2026
  • K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port…Bard Access Systems, Inc. · 2025
  • K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port…Bard Access Systems, Inc. · 2025
  • K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsBard Access Systems, Inc. · 2024
  • K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable…Bard Peripheral Vascular, Inc. · 2023

https://510kreport.com/device/K130576 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130576: Celsite Implantable Access Port Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130576

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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