510(k) · Cleared
ClearedPolysite Implantable Infusion Ports
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perouse Medical · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Cleared on Dec 11, 2013 as substantially equivalent to K072215 (C.R. Bard, Inc., 2007) and 1 other predicate after a 450-day review. Its family tree reaches back 9 generations to 2000.
- Decided
- Dec 11, 2013
- Review
- 450 days
- Class
- Class II
- Product code
- LJT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K001901 (2000). 22 ancestors in all, the oldest K863606 (1986). No later device cites it as a predicate yet.
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 2 generations backK063377 Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterC.R. Bard, Inc. · 2007 · Recalled
- 1 generation backK072215 Titanium Powerport Isp Implanted PortC.R. Bard, Inc. · 2007
- This deviceK122834 Polysite Implantable Infusion PortsPerouse Medical · 2013
Show all 9 generations
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 6 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 4 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 3 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 2 generations backK063377 Powerport Polymetric Port with 8 FR S/L Chronoflex CatheterC.R. Bard, Inc. · 2007 · Recalled
- 1 generation backK072215 Titanium Powerport Isp Implanted PortC.R. Bard, Inc. · 2007
- This deviceK122834 Polysite Implantable Infusion PortsPerouse Medical · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −8 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −7 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −6 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −4 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −3 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| −2 | K063377 | Powerport Polymetric Port with 8 FR S/L Chronoflex Catheter | C.R. Bard, Inc. | 2007 | 7 |
| −1 | K072215 | Titanium Powerport Isp Implanted Port | C.R. Bard, Inc. | 2007 | — |
| 0 (this device) | K122834 | Polysite Implantable Infusion Ports | Perouse Medical | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 4 | 0 |
| 1991 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K072215 | Titanium Powerport Isp Implanted PortSummary page 1…ULAR Legally marketed - PowerPort isp Implantable Port with attachable SFr. Chronoifiex predicate devices Polyurethane Catheter (K072215) Titanium implantable port with attachable 6F… | 2007 |
| * | K870260 | Hickman Titanium Subcutaneous PortSummary page 1…-Slimport Chronoflex Open-ended single-lumen venous catheter -- (K870260) ___ ______ Deiscription POLYSITE ImplantableInfusion Port is composed of a radiop… | 1987 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 12 of the 22 ancestors have a recall of any class.
- 1 other device also cites its predicate K072215.
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. 2013, 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?
The POLYSITE implantable infusion Port is indicated for long term access to the central venous system and allows for repeated vascular access. POLYSITE Implantable Infusion venous access ports are used to administer chemotherapy, antibiotics and antiviral drugs. They can also be used for parenteral nutrition, collection of blood samples and transfusion of blood or blood products. A non-coring needle must be used to access POLYSITE Implantable Infusion…
Read the full statement (147 words)
The POLYSITE implantable infusion Port is indicated for long term access to the central venous system and allows for repeated vascular access.
POLYSITE Implantable Infusion venous access ports are used to administer chemotherapy, antibiotics and antiviral drugs. They can also be used for parenteral nutrition, collection of blood samples and transfusion of blood or blood products.
A non-coring needle must be used to access POLYSITE Implantable Infusion Ports.
Some references of POLYSITE (POLYSITE Pressure Injectable Implantable Infusion Port-PI references) can be used for high pressure injection of contrast media during diagnostic studies. The maximum flow rate of power injector equipment used with the pressure injectable port may not exceed 5 mL/s.
For high pressure injection of contrast media, a high pressure needle must be used to access the POLYSITE Pressure Injectable implantable Infusion port. The manufacturer recommends the use of PPS P1 Pressure Injectable Safety Huber needle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122834 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122834: Polysite Implantable Infusion Ports.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122834
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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