510(k) Report

510(k) · Cleared

Recalled · Class I · 2025

Plastic Port Implantable Venous Access System

K994216510(k) TraditionalCleared Jan 27, 200043-day reviewClass II21 CFR 880.5965Recalls 11 (6 Class I)

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

Sims Deltec, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on Jan 27, 2000 as substantially equivalent to K830730 (Pharmacia, Inc., 1983) and 3 other predicates after a 43-day review. Its family tree reaches back 1 generation to 1983. 1 of the 5 devices in its family, counting itself, has a Class I recall. It has been recalled 11 times, including 6 Class I recalls.

Decided
Jan 27, 2000
Review
43 days
Class
Class II
Product code
LJT
Recalls
11 (6 Class I)
Predicates
4

Its longest line of descent runs back 1 generation to K830730 (1983). 4 ancestors in all. No later device cites it as a predicate yet. 1 of the 5 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 1994: 2 other ancestors1988: 1 other ancestorK830730 · Port-a-Cath Implantable Cath. Sys · Pharmacia, Inc. · 1983 · recalled19801985199019952000
Other ancestors, by generation 1 generation back: 3 other ancestors K830730 · Port-a-Cath Implantable Cath. Sys · Pharmacia, Inc. · 1983 · recalled0
  1. Root · 1 generation backK830730 Port-a-Cath Implantable Cath. SysPharmacia, Inc. · 1983 · Recalled
  2. This deviceK994216 Plastic Port Implantable Venous Access SystemSims Deltec, Inc. · 2000
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K830730Port-a-Cath Implantable Cath. SysPharmacia, Inc.19831
0 (this device)K994216Plastic Port Implantable Venous Access SystemSims Deltec, Inc.2000—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199420
FIG. 1 — Lineage of K994216, 1983–2000Source: 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.

1 device in this family has a Class I recall. 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
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What was it cleared against? (5)

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
*K830730Port-a-Cath Implantable Cath. Sys
Summary page 2
…PARISON Plastic Port Systems PORT-A-CATH® M.R.L.® Implanted Systems Port MANUFACTURER SIMS Deltec, Inc. SIMS Deltec, Inc. Bard Access System 510(K) NUMBER Subject Device K830730B Unknown K875276 K932840 K942024 INDICATION FOR USE A system is indicated A system is indicated The BardPort Implanted when patie…
Pharmacia, Inc.19831
*K875276Port-a-Cath (R) Implantable Drug Delivery System
Summary page 2
…ort Systems PORT-A-CATH® M.R.L.® Implanted Systems Port MANUFACTURER SIMS Deltec, Inc. SIMS Deltec, Inc. Bard Access System 510(K) NUMBER Subject Device K830730B Unknown K875276 K932840 K942024 INDICATION FOR USE A system is indicated A system is indicated The BardPort Implanted when patient therapy when p…
Pharmacia Deltec, Inc.1988—
*K932840Port-a-Cath Implantable Vascular Access System
Summary page 2
…ems PORT-A-CATH® M.R.L.® Implanted Systems Port MANUFACTURER SIMS Deltec, Inc. SIMS Deltec, Inc. Bard Access System 510(K) NUMBER Subject Device K830730B Unknown K875276 K932840 K942024 INDICATION FOR USE A system is indicated A system is indicated The BardPort Implanted when patient therapy when patient t…
Pharmacia Deltec, Inc.19942
*K942024Port-a-Cath Low Profile Implantable Venous Access System
Summary page 2
…-A-CATH® M.R.L.® Implanted Systems Port MANUFACTURER SIMS Deltec, Inc. SIMS Deltec, Inc. Bard Access System 510(K) NUMBER Subject Device K830730B Unknown K875276 K932840 K942024 INDICATION FOR USE A system is indicated A system is indicated The BardPort Implanted when patient therapy when patient therapy P…
Pharmacia Deltec, Inc.19948
*—M.R.L® Implanted Ports
Named without a submission number
—

Also cleared against K830730: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 13, 2025Class IZ-1287-2025Process controlThe plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Feb 13, 2025Class IZ-1281-2025Process controlThe plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Feb 13, 2025Class IZ-1282-2025Process controlThe plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Feb 13, 2025Class IZ-1280-2025Process controlThe plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Feb 13, 2025Class IZ-1283-2025Process controlThe plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Feb 13, 2025Class IZ-1288-2025Process controlThe plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Mar 29, 2004Not classifiedZ-0874-04OtherSome of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Mar 29, 2004Not classifiedZ-0871-04OtherSome of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Mar 29, 2004Not classifiedZ-0875-04OtherSome of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Mar 29, 2004Not classifiedZ-0872-04OtherSome of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.
Mar 29, 2004Not classifiedZ-0873-04OtherSome of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization.

The 5 latest of 11 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 3 of the 4 ancestors have a recall of any class.
  • 1 other device also cites its predicate K830730.

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?

A system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K830730

1 other device cites the same predicate.

  • K992697Port-a-Cath II Trans-Arterial Percutaneous SystemSims Deltec, Inc. · 1999

More from Sims Deltec, Inc.

32 FDA decisions under this applicant name. See the company

  • K010426Proport Plastic Venous Implantable Access Systems Pre-Assembled with Silicone CatheterSims Deltec, Inc. · 2001
  • K000842Cadd-Prizm PCS II Model 6101 Ambulatory Infusion SystemSims Deltec, Inc. · 20002 recalls
  • K000942Cadd Checkvalve Administration Set, Model 21-7090Sims Deltec, Inc. · 2000
  • K992697Port-a-Cath II Trans-Arterial Percutaneous SystemSims Deltec, Inc. · 1999
  • K992880P.a.S. Port Elite Implantable Venous Access SystemSims Deltec, Inc. · 19992 recalls

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/K994216 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994216: Plastic Port Implantable Venous Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994216

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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