510(k) · Decided
DecidedDermaport Percutaneous 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 Nov 30, 2007 as substantially equivalent to K994105 (Medical Components, Inc., 2001) and 1 other predicate after a 213-day review. Its family tree reaches back 5 generations to 2002. 1 later device descends from it.
- Decided
- Nov 30, 2007
- Review
- 213 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K013160 (2002). 9 ancestors in all, the oldest K894131 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK013160 Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc. · 2002
- 4 generations backK021212 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
- 3 generations backK022000 Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
- 2 generations backK043292 HemocathMed-Conduit, Inc. · 2005
- 1 generation backK062901 Hemocath IIMed-Conduit, Inc. · 2007
- This deviceK071202 Dermaport Percutaneous Vascular Access System (Pvas)Dermaport, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK091760 Dermaport Ported Vascular Access System (Pvas)Dermaport, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K091760Dermaport Ported Vascular Access System (Pvas)Dermaport, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K013160 | Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter | Spire Biomedical, Inc. | 2002 | — |
| −4 | K021212 | 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated… | Spire Biomedical, Inc. | 2002 | — |
| −3 | K022000 | Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips… | Spire Biomedical, Inc. | 2002 | — |
| −2 | K043292 | Hemocath | Med-Conduit, Inc. | 2005 | — |
| −1 | K062901 | Hemocath II | Med-Conduit, Inc. | 2007 | — |
| 0 (this device) | K071202 | Dermaport Percutaneous Vascular Access System (Pvas) | Dermaport, Inc. | 2007 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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 12.3 · 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? (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 |
|---|---|---|---|
| * | K994105 | Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40Summary page 1…ssories, Class 111, Product Code: MSD Predicate Device(s): 510(k) Number: Manufacture: Trade Name: 510(k) Number: Manufacture: Trade Name: 1.0 Description of Device K994105 MEDCOMP® Medcomp Hemo-Flow Catheter K 062901 Med-Conduit Inc. HemoCath 11 The DermaPort Percutaneous Vascular Access System (PV… | 2001 |
| * | K062901 | Hemocath IISummary page 1…ate Device(s): 510(k) Number: Manufacture: Trade Name: 510(k) Number: Manufacture: Trade Name: 1.0 Description of Device K994105 MEDCOMP® Medcomp Hemo-Flow Catheter K 062901 Med-Conduit Inc. HemoCath 11 The DermaPort Percutaneous Vascular Access System (PVAS) is designed to facilitate catheter placem… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091760 | Dermaport Ported Vascular Access System (Pvas) | 2009 | 0 |
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 5 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K091760 (Dermaport, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K994105.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Percutaneous Vascular Access Syster (PVAS™) is indicated for long-term (greater than 30 days) vascular access for hemodialysis and apheresis. The system is inscrted percutaneously and the catheter is typically placed in the internal jugular vein of an adult patient. The subclavian vein is an alternate catheter insertion site.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K071202 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071202: Dermaport Percutaneous Vascular Access System (Pvas).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071202
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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