510(k) · Cleared
ClearedDermaport Ported Vascular Access System (Pvas)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dermaport, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Jul 20, 2009 as substantially equivalent to K071202 (Dermaport, Inc., 2007) after a 34-day review. Its family tree reaches back 6 generations to 2002.
- Decided
- Jul 20, 2009
- Review
- 34 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K013160 (2002). 10 ancestors in all, the oldest K894131 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK013160 Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc. · 2002
- 5 generations backK021212 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
- 4 generations backK022000 Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
- 3 generations backK043292 HemocathMed-Conduit, Inc. · 2005
- 2 generations backK062901 Hemocath IIMed-Conduit, Inc. · 2007
- 1 generation backK071202 Dermaport Percutaneous Vascular Access System (Pvas)Dermaport, Inc. · 2007
- This deviceK091760 Dermaport Ported Vascular Access System (Pvas)Dermaport, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K013160 | Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter | Spire Biomedical, Inc. | 2002 | — |
| −5 | K021212 | 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated… | Spire Biomedical, Inc. | 2002 | — |
| −4 | K022000 | Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips… | Spire Biomedical, Inc. | 2002 | — |
| −3 | K043292 | Hemocath | Med-Conduit, Inc. | 2005 | — |
| −2 | K062901 | Hemocath II | Med-Conduit, Inc. | 2007 | — |
| −1 | K071202 | Dermaport Percutaneous Vascular Access System (Pvas) | Dermaport, Inc. | 2007 | — |
| 0 (this device) | K091760 | Dermaport Ported Vascular Access System (Pvas) | Dermaport, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 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 MSD? 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 MSD device
- #1 K241581 Hemodialysis Catheterscore 12.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K071202 | Dermaport Percutaneous Vascular Access System (Pvas)Summary page 1…e and Accessories, Class 1II, Product Code: MSD Predicate Device: 5 10(k) Number: K07 1202 Manufacture: DermaPort Trade Name:… | 2007 |
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 7 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 10 ancestors have a recall of any class.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · MSD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSD
153in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSD
1in 2013
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MSD
1,054in 2025
MAUDE reports naming product code MSD, 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 | 7 | 92 | 0 | 118 |
| 2008 | 3 | 89 | 47 | 174 |
| 2009 | 6 | 81 | 49 | 173 |
| 2010 | 4 | 116 | 11 | 306 |
| 2011 | 7 | 70 | 24 | 268 |
| 2012 | 2 | — | 0 | 367 |
| 2013 | 5 | 105 | 1 | 363 |
| 2014 | 8 | 246 | 0 | 506 |
| 2015 | 1 | — | 0 | 550 |
| 2016 | 2 | — | 0 | 532 |
| 2017 | 2 | — | 0 | 484 |
| 2018 | 2 | — | 0 | 463 |
| 2019 | 1 | — | 0 | 645 |
| 2020 | 4 | 106 | 0 | 401 |
| 2021 | 4 | 153 | 0 | 523 |
| 2022 | 0 | — | 0 | 610 |
| 2023 | 0 | — | 0 | 542 |
| 2024 | 0 | — | 0 | 841 |
| 2025 | 1 | — | 0 | 1,054 |
| 2026 | 0 | — | 4 (4) | — |
What is it indicated for?
The DermaPort Ported Vascular Access System (PVASTM) is indicated for long-term (greater than 30 days) vascular access for hemodialysis and apheresis. The system is inserted percutaneously and typically placed in the internal jugular vein of an adult patient. The subclavian vein is an alternate catheter insertion site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091760 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091760: Dermaport Ported Vascular Access System (Pvas).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091760
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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