510(k) Report

510(k) · Cleared

Cleared

Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power Gripper Plus Needle

K070116510(k) TraditionalCleared May 23, 2007131-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 23, 2007 as substantially equivalent to K864446 (Pharmacia, Inc., 1987) and 8 other predicates after a 131-day review. Its family tree reaches back 7 generations to 2000. 18 later devices descend from it.

Decided
May 23, 2007
Review
131 days
Class
Class II
Product code
LJT
Recalls
None
Predicates
9

Its longest line of descent runs back 7 generations to K001901 (2000). 28 ancestors in all, the oldest K863606 (1986). 18 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2002: 1 other ancestor1996: 1 other ancestor1994: 3 other ancestors1988: 1 other ancestor1987: 2 other ancestors2005: 2 other ancestors2004: 2 other ancestors2001: 1 other ancestor2000: 1 other ancestor1986: 1 other ancestor1991: 1 other ancestor1989: 4 other ancestors2010: 1 descendant cleared2011: 2 descendants cleared2008: 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 clearedK001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalledK012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K034019 · Poly Per-Q-Cath Picc Catheters · C.R. Bard, Inc. · 2004 · recalledK050931 · 6 FR DL Powerpicc Catheter · C.R. Bard, Inc. · 2005K051672 · Powerpicc · Bard Access Systems, Inc. · 2005 · recalledK060812 · Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple · C.R. Bard, Inc. · 2006 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 3 other ancestors5 generations back: 5 other ancestors 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 5 descendants4 generations forward: 5 descendants5 generations forward: 1 descendant K060812 · Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple · C.R. Bard, Inc. · 2006 · recalledK051672 · Powerpicc · Bard Access Systems, Inc. · 2005 · recalledK050931 · 6 FR DL Powerpicc Catheter · C.R. Bard, Inc. · 2005K034019 · Poly Per-Q-Cath Picc Catheters · C.R. Bard, Inc. · 2004 · recalledK031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalled−50+5
  1. Root · 7 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 6 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 5 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 4 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
  5. 3 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
  6. 2 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
  7. 1 generation backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
  8. This deviceK070116 Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous…Smiths Medical MD, Inc. · 2007
  9. Descendant · cites it directly · 13 of its ownK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled
  10. Descendant · 2 generations on · 6 of its ownK170897 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety…B.Braun Medical, Inc. · 2017
  11. Descendant · 3 generations on · 2 of its ownK230715 Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2023
  12. Descendant · 3 generations on · 2 of its ownK200463 Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd · 2021
  13. Descendant · 2 generations on · 2 of its ownK153440 PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc. · 2016 · Recalled

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 12011: 22014: 12016: 12017: 22020: 12021: 32023: 12024: 12025: 22026: 1
2008high 3 (2021) · low 0 (2012)2026

Most influential descendants

Showing 5 of 18 · See all
  • K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · cites it directly13descendants
  • K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with…B.Braun Medical, Inc. · 2017 · 2 generations on6descendants
  • K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2023 · 3 generations on2descendants
  • K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd · 2021 · 3 generations on2descendants
  • K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc. · 2016 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−6K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−5K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−4K034019Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc.20041
−3K0509316 FR DL Powerpicc CatheterC.R. Bard, Inc.2005—
−2K051672PowerpiccBard Access Systems, Inc.20051
−1K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.20061
0 (this device)K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems…Smiths Medical MD, Inc.2007—
+1K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc.20082
+2K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle…B.Braun Medical, Inc.2017—
+3K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.2023—
+3K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd2021—
+2K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc.201612

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198720
198810
198940
199110
199430
199610
200010
200110
200210
200420
200520
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201010
201120
201410
201610
201720
202010
202130
202310
202410
202520
202610
FIG. 1 — Lineage of K070116, 2000–2026Source: 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? (9)

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
*K864446Port-a-Cath Vascular Access Systems
Summary page 2
…Needle 510(k) Summary Catheter/Port Device Name/5 10(k) number: PORT-A-CATH® implantable venous access system (K864446, K875276, K932095, K942024, and K060036) PORT-A-CATH® II implantable venous access system (K932840, K942024, K962…
Pharmacia, Inc.1987—
*K875276Port-a-Cath (R) Implantable Drug Delivery System
Summary page 2
…510(k) Summary Catheter/Port Device Name/5 10(k) number: PORT-A-CATH® implantable venous access system (K864446, K875276, K932095, K942024, and K060036) PORT-A-CATH® II implantable venous access system (K932840, K942024, K962695, and…
Pharmacia Deltec, Inc.1988—
*K932095Port-a-Cath Dual Lumen Implantable Venous Access S
Summary page 2
…510(k) Summary Catheter/Port Device Name/5 10(k) number: PORT-A-CATH® implantable venous access system (K864446, K875276, K932095, K942024, and K060036) PORT-A-CATH® II implantable venous access system (K932840, K942024, K962695, and K…
Pharmacia Deltec, Inc.19941
*K942024Port-a-Cath Low Profile Implantable Venous Access System
Summary page 2
…510(k) Summary Catheter/Port Device Name/5 10(k) number: PORT-A-CATH® implantable venous access system (K864446, K875276, K932095, K942024, and K060036) PORT-A-CATH® II implantable venous access system (K932840, K942024, K962695, and K060036) P…
Pharmacia Deltec, Inc.19948
*K060036Port-a-Cath, Port-a-Cath II, Proport and P.a.S. Port Implantable Venous Access Systems…
Summary page 2
…510(k) Summary Catheter/Port Device Name/5 10(k) number: PORT-A-CATH® implantable venous access system (K864446, K875276, K932095, K942024, and K060036) PORT-A-CATH® II implantable venous access system (K932840, K942024, K962695, and K060036) PowerPortT M I…
Smiths Medical MD, Inc.2006—
*K932840Port-a-Cath Implantable Vascular Access System
Summary page 2
…PORT-A-CATH® implantable venous access system (K864446, K875276, K932095, K942024, and K060036) PORT-A-CATH® II implantable venous access system (K932840, K942024, K962695, and K060036) PowerPortT M Implanted Titanium Port with 8Fr. ChronoFlex® (K060812) Needle…
Pharmacia Deltec, Inc.19942
*K962695Port-a-Cath II Venous Implantable Access Systems Preconnected with Polyurethane Catheter
Summary page 2
…H® implantable venous access system (K864446, K875276, K932095, K942024, and K060036) PORT-A-CATH® II implantable venous access system (K932840, K942024, K962695, and K060036) PowerPortT M Implanted Titanium Port with 8Fr. ChronoFlex® (K060812) Needle Device Name/5 1…
Sims Deltec, Inc.19966
*K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple
Summary page 2
…PORT-A-CATH® II implantable venous access system (K932840, K942024, K962695, and K060036) PowerPortT M Implanted Titanium Port with 8Fr. ChronoFlex® (K060812) Needle Device Name/5 10(k) number: GRIPPER PLUS® needle (K021999) VI. Device Description PORT-A-CATH® and PO…
C.R. Bard, Inc.20061
*K021999Gripper Plus Needle
Summary page 2
…nd K060036) PowerPortT M Implanted Titanium Port with 8Fr. ChronoFlex® (K060812) Needle Device Name/5 10(k) number: GRIPPER PLUS® needle (K021999) VI. Device Description PORT-A-CATH® and PORT-A-CATH-® II POWER P.A.C. Implantable Venous Access Systems The PORT-A-C…
Deltec, Inc.20021

What descends from it? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc.200813
K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical20112
K093414Port-a-Cath Power P.a.C. Implantable Venous Access SystemsSmiths Medical Asd, Inc.20100

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?

  • The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 10 months on median.
  • 16 of the 28 ancestors have a recall of any class.
  • Of its descendants, K073050 (Specialized Health Products International, Inc., 2008) has gone furthest, with 13 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. 2007, 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?

The PORT-A-CATH® POWER P.A.C. implantable venous access systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling. When used with a GRIPPER PLUS® POWER P.A.C. needle, the PORT-A-CATH® POWER P.A.C. implantable venous access system is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec. The…

Read the full statement (224 words)

The PORT-A-CATH® POWER P.A.C. implantable venous access systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.

When used with a GRIPPER PLUS® POWER P.A.C. needle, the PORT-A-CATH® POWER P.A.C. implantable venous access system is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.

The PORT-A-CATH® II POWER P.A.C. implantable venous access system is indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.

When used with a GRIPPER PLUS® POWER P.A.C. needle, the PORT-A-CATH® II POWER P.A.C. implantable venous access system is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.

The GRIPPER PLUS' POWER P.A.C. needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries.

When used with the PORT-A-CATH® POWER P.A.C. and POWER PORT-A-CATIH® II POWER P.A.C. implantable venous access systems, the GRIPPER PLUS® POWER P.A.C. needle is also indicated for power injection of contrast media into the central venous system. The maximum recommended infusion rate is 5 ml/sec. for 19 and 20 gauge needles and 3ml/sec. for 22 gauge needles.

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/K070116 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070116: Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power Gripper Plus Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070116

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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