510(k) · Cleared
Recalled · Class II · 2020Power Port-a-Cath, Cath II, and P.a.S. Port T2 Power P.a.C. Implantable Venous Access Systems and Power Gripper Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical MD, Inc. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Dec 14, 2007 after an 85-day review. The FDA summary names its predicate without a number. It has been recalled 2 times.
- Decided
- Dec 14, 2007
- Review
- 85 days
- Class
- Class II
- Product code
- LJT
- Recalls
- 2
- Predicates
- 0
The FDA summary names its predicate without a number.
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 K251253 PowerPort™ isp Implantable Port; PowerPort™…score 14.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Smiths Medical MD, Inc. PORT-A-CATH and PORT-A-CATH II POWER P.A.C. Implantable Venous… Named without a submission number | |
| * | — | Smiths Medical MD, Inc. Gripper Plus POWER P.A.C. Needle Named without a submission number | |
| * | — | Smiths Medical MD, Inc. P.A.S. Port T2 Implantable Venous Access System Named without a submission number | |
| * | — | Smiths Medical MD, Inc. PORT-A-CATH II 7 French, Dual Lumen Low Profile Implantable… Named without a submission number | |
| * | — | Medcomp Power Injectable Implantable Infusion Port Named without a submission number |
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
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 11, 2020 | Class II | Z-2499-2020 | Under Investigation by firm | Smiths Medical became aware that one (1) lot of PORT-A-CATH¿ II POWER P.A.C. Low Profile" System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter. |
| Jul 8, 2019 | Class II | Z-0190-2020 | Process control | Potential for certain GRIPPER Needles to contain an occluded or blocked needle. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LJT devicesLJT 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
2026 to Oct 25, outlined.
Median 510(k) review, days · LJT
182in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJT
1in 2022
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · LJT
4,308in 2025
MAUDE reports naming product code LJT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 85 | 1 | 208 |
| 2008 | 7 | 119 | 2 | 161 |
| 2009 | 2 | — | 2 | 172 |
| 2010 | 2 | — | 19 | 207 |
| 2011 | 5 | 144 | 1 | 202 |
| 2012 | 2 | — | 2 | 153 |
| 2013 | 7 | 150 | 0 | 141 |
| 2014 | 2 | — | 0 | 143 |
| 2015 | 4 | 164 | 1 | 149 |
| 2016 | 3 | 182 | 0 | 135 |
| 2017 | 0 | — | 1 | 262 |
| 2018 | 0 | — | 1 | 878 |
| 2019 | 1 | — | 7 | 765 |
| 2020 | 1 | — | 0 | 959 |
| 2021 | 0 | — | 0 | 1,285 |
| 2022 | 0 | — | 1 | 1,334 |
| 2023 | 1 | — | 0 | 1,221 |
| 2024 | 1 | — | 0 | 1,896 |
| 2025 | 2 | — | 0 | 4,308 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
Smiths Medical MD, Inc. 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. Safety Huber Needle or other power injectable huber needle, the Smiths Medical MD, Inc. POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injection of…
Read the full statement (140 words)
Smiths Medical MD, Inc. 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. Safety Huber Needle or other power injectable huber needle, the Smiths Medical MD, Inc. POWER P.A.C. implantable venous access systems are 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. Safety Huber 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 power injectable implantable venous access ports, the GRIPPER PLUS POWER P.A.C. Safety Huber Needle is indicated for power injection of contrast media.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072657 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072657: Power Port-a-Cath, Cath II, and P.a.S. Port T2 Power P.a.C. Implantable Venous Access Systems and Power Gripper Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072657
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026