510(k) Report

510(k) · Cleared

Recalled · 2011

Celsite/ Celsite Concept, Access Ports

K061424510(k) TraditionalCleared Jul 31, 200669-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

Aesculap, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on Jul 31, 2006 as substantially equivalent to K902401 (Burron Medical, Inc., 1991) and 7 other predicates after a 69-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it. It has been recalled 2 times.

Decided
Jul 31, 2006
Review
69 days
Class
Class II
Product code
LJT
Recalls
2
Predicates
8

Its longest line of descent runs back 2 generations to K952548 (1995). 13 ancestors in all, the oldest K830730 (1983). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor1995: 2 other ancestors1994: 3 other ancestors1991: 1 other ancestor2001: 1 other ancestor1983: 1 other ancestor2013: 1 descendant clearedK952548 · Celsite Venous System · B.Braun Medical, Inc. · 1995 · recalledK962230 · Celsite Port with Preconnected Catheter · B.Braun Medical, Inc. · 1996 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 5 other ancestors 1 generation forward: 1 descendant K962230 · Celsite Port with Preconnected Catheter · B.Braun Medical, Inc. · 1996 · recalledK952548 · Celsite Venous System · B.Braun Medical, Inc. · 1995 · recalled0
  1. Root · 2 generations backK952548 Celsite Venous SystemB.Braun Medical, Inc. · 1995 · Recalled
  2. 1 generation backK962230 Celsite Port with Preconnected CatheterB.Braun Medical, Inc. · 1996 · Recalled
  3. This deviceK061424 Celsite/ Celsite Concept, Access PortsAesculap, Inc. · 2006
  4. Descendant · cites it directly · 0 of its ownK130576 Celsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc. · 2013 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
−2K952548Celsite Venous SystemB.Braun Medical, Inc.19952
−1K962230Celsite Port with Preconnected CatheterB.Braun Medical, Inc.19961
0 (this device)K061424Celsite/ Celsite Concept, Access PortsAesculap, Inc.2006—
+1K130576Celsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc.20132

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199110
199430
199520
199910
200010
200110
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K061424, 1995–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K902401Celsite (TM) Implantable Drug Delivery System
Summary page 1
…Aesculap®, Inc. believes that the Celsite®/ Celsite® Concept TM Access Ports are substantially equivalent to Aesculap's currently marketed Celsite® Access Port Systems (K902401, K952548, K954297, K962230, K993024) and Deltec Inc., PORT-A-CATH® II (K032557, K992697, K932840). DEVICE DESCRIPTION The Celsit…
Burron Medical, Inc.1991—
*K952548Celsite Venous System
Summary page 1
…®, Inc. believes that the Celsite®/ Celsite® Concept TM Access Ports are substantially equivalent to Aesculap's currently marketed Celsite® Access Port Systems (K902401, K952548, K954297, K962230, K993024) and Deltec Inc., PORT-A-CATH® II (K032557, K992697, K932840). DEVICE DESCRIPTION The Celsite®/ Celsi…
B.Braun Medical, Inc.19952
*K954297Celsite Venous Access System Otw
Summary page 1
…elieves that the Celsite®/ Celsite® Concept TM Access Ports are substantially equivalent to Aesculap's currently marketed Celsite® Access Port Systems (K902401, K952548, K954297, K962230, K993024) and Deltec Inc., PORT-A-CATH® II (K032557, K992697, K932840). DEVICE DESCRIPTION The Celsite®/ Celsite® Conce…
B.Braun Medical, Inc.1995—
*K962230Celsite Port with Preconnected Catheter
Summary page 1
…hat the Celsite®/ Celsite® Concept TM Access Ports are substantially equivalent to Aesculap's currently marketed Celsite® Access Port Systems (K902401, K952548, K954297, K962230, K993024) and Deltec Inc., PORT-A-CATH® II (K032557, K992697, K932840). DEVICE DESCRIPTION The Celsite®/ Celsite® Concept Tm Acc…
B.Braun Medical, Inc.19961
*K993024Celsite Implantable Port with Valved Catheter
Summary page 1
…elsite®/ Celsite® Concept TM Access Ports are substantially equivalent to Aesculap's currently marketed Celsite® Access Port Systems (K902401, K952548, K954297, K962230, K993024) and Deltec Inc., PORT-A-CATH® II (K032557, K992697, K932840). DEVICE DESCRIPTION The Celsite®/ Celsite® Concept Tm Access Ports…
B. Braun of America, Inc.20001
*K032557Triumph VTX with Lifevalve Catheter
Summary page 1
…re substantially equivalent to Aesculap's currently marketed Celsite® Access Port Systems (K902401, K952548, K954297, K962230, K993024) and Deltec Inc., PORT-A-CATH® II (K032557, K992697, K932840). DEVICE DESCRIPTION The Celsite®/ Celsite® Concept Tm Access Ports are an implantable port and catheter syste…
Horizon Medical Products, Inc.20031
*K992697Port-a-Cath II Trans-Arterial Percutaneous System
Summary page 1
…ntially equivalent to Aesculap's currently marketed Celsite® Access Port Systems (K902401, K952548, K954297, K962230, K993024) and Deltec Inc., PORT-A-CATH® II (K032557, K992697, K932840). DEVICE DESCRIPTION The Celsite®/ Celsite® Concept Tm Access Ports are an implantable port and catheter system which a…
Sims Deltec, Inc.1999—
*K932840Port-a-Cath Implantable Vascular Access System
Summary page 1
…quivalent to Aesculap's currently marketed Celsite® Access Port Systems (K902401, K952548, K954297, K962230, K993024) and Deltec Inc., PORT-A-CATH® II (K032557, K992697, K932840). DEVICE DESCRIPTION The Celsite®/ Celsite® Concept Tm Access Ports are an implantable port and catheter system which allows saf…
Pharmacia Deltec, Inc.19942

Also cleared against K902401: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K130576Celsite Implantable Access Port SystemsB. Braun Interventional Systems, Inc.20130

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 13, 2011Not classifiedZ-2671-2011Process designThe 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, 2009Not classifiedZ-1961-2009Nonconforming Material/ComponentB. 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?

  • The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
  • 9 of the 13 ancestors have a recall of any class.
  • Of its descendants, K130576 (B. Braun Interventional Systems, Inc., 2013) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K902401.

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.

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?

The Aesculap 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.

Indications for use as stated in the FDA summary.

Also cleared against K902401

1 other device cites the same predicate.

  • K952435Celsite Pediatric Venous SystemB.Braun Medical, Inc. · 19961 recall

More from Aesculap, Inc.

208 FDA decisions under this applicant name. See the company

  • K260044Ventricular Catheters, Thomale CatheterAesculap, Inc. · 2026
  • K242762Aesculap Aicon® Series Container SystemAesculap, Inc. · 2025
  • K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc. · 2024
  • K223596SQ.line KERRISONAesculap, Inc. · 2023
  • K214041Aesculap AICON ContainerAesculap, Inc. · 2022

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/K061424 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061424: Celsite/ Celsite Concept, Access Ports.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061424

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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