510(k) Report

510(k) · Cleared

Cleared

Port-a-Cath, Port-a-Cath II, Proport and P.a.S. Port Implantable Venous Access Systems with Dual Layer Catheter

K060036510(k) TraditionalCleared May 17, 2006132-day reviewClass II21 CFR 880.5965

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

Smiths Medical MD, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on May 17, 2006 after a 132-day review. The FDA summary names its predicate without a number. 21 later devices descend from it.

Decided
May 17, 2006
Review
132 days
Class
Class II
Product code
LJT
Recalls
None
Predicates
0

21 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2011: 3 descendants cleared2010: 1 descendant cleared2008: 1 descendant cleared2015: 1 descendant cleared2016: 1 descendant cleared2009: 1 descendant cleared2017: 2 descendants cleared2014: 1 descendant cleared2020: 1 descendant cleared2021: 3 descendants cleared2023: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared2025: 2 descendants cleared20052010201520202025
  1. This deviceK060036 Port-a-Cath, Port-a-Cath II, Proport and P.a.S. Port Implantable…Smiths Medical MD, Inc. · 2006
  2. Descendant · cites it directly · 18 of its ownK070116 Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous…Smiths Medical MD, Inc. · 2007
  3. Descendant · 2 generations on · 13 of its ownK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled
  4. Descendant · 3 generations on · 6 of its ownK170897 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety…B.Braun Medical, Inc. · 2017
  5. Descendant · 4 generations on · 2 of its ownK230715 Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2023
  6. Descendant · 4 generations on · 2 of its ownK200463 Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd · 2021

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12009: 12010: 12011: 32014: 12015: 12016: 12017: 22020: 12021: 32023: 12024: 12025: 22026: 1
2007high 3 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 21 · See all
  • K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Smiths Medical MD, Inc. · 2007 · cites it directly18descendants
  • K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · 2 generations on13descendants
  • K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with…B.Braun Medical, Inc. · 2017 · 3 generations on6descendants
  • K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2023 · 4 generations on2descendants
  • K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd · 2021 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K060036Port-a-Cath, Port-a-Cath II, Proport and P.a.S. Port Implantable Venous Access…Smiths Medical MD, Inc.2006—
+1K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems…Smiths Medical MD, Inc.2007—
+2K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc.20082
+3K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle…B.Braun Medical, Inc.2017—
+4K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.2023—
+4K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
200910
201010
201130
201410
201510
201610
201720
202010
202130
202310
202410
202520
202610
FIG. 1 — Lineage of K060036, 2006–2026Source: 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? (4)

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
*—PORT-A-CATH® Implantable Venous Access Systems
Named without a submission number
—
*—PORT-A-CATH® II Implantable Venous Access Systems
Named without a submission number
—
*—ProPort® Implantable Venous Access Systems
Named without a submission number
—
*—P.A.S. PORT® Implantable Venous Access Systems
Named without a submission number
—

What descends from it? (21)

See all 21

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Smiths Medical MD, Inc.200718
K110407InvisiportStealth Therapeutics, Incorporated20111

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, K070116 (Smiths Medical MD, Inc., 2007) has gone furthest, with 18 descendants of its own.

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?

PORT-A-CATH® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling. PORT-A-CATH® II Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling. ProPort® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated…

Read the full statement (98 words)

PORT-A-CATH® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.

PORT-A-CATH® II Systems with Dual Layer Catheter are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.

ProPort® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

P.A.S. PORT® Systems with Dual Layer Catheter are indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Indications for use as stated in the FDA summary.

More from Smiths Medical MD, Inc.

20 FDA decisions under this applicant name. See the company

  • K112407Smith Medical Peel-Away Sheath IntroducersSmiths Medical MD, Inc. · 2012
  • K111386Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported…Smiths Medical MD, Inc. · 20116 Class I recalls
  • K101180Gripper Micro Blunt Cannula, Non-Coring Safety Needle (Gripper Micro Needle) Model: 21-3253-24, 21-3258-24…Smiths Medical MD, Inc. · 2010
  • K091181Lockbox for Use with Medfusion 3000 Series PumpsSmiths Medical MD, Inc. · 2009
  • K082783Cadd -Solis Medication Safety Software: Administrator and Point-of-CareSmiths Medical MD, Inc. · 2008

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/K060036 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060036: Port-a-Cath, Port-a-Cath II, Proport and P.a.S. Port Implantable Venous Access Systems with Dual Layer Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060036

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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