510(k) · Cleared
ClearedHemocath II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Med-Conduit, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Feb 8, 2007 as substantially equivalent to K043292 (Med-Conduit, Inc., 2005) after a 134-day review. Its family tree reaches back 4 generations to 2002. 2 later devices descend from it.
- Decided
- Feb 8, 2007
- Review
- 134 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K013160 (2002). 6 ancestors in all, the oldest K894131 (1989). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK013160 Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc. · 2002
- 3 generations backK021212 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
- 2 generations backK022000 Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
- 1 generation backK043292 HemocathMed-Conduit, Inc. · 2005
- This deviceK062901 Hemocath IIMed-Conduit, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK071202 Dermaport Percutaneous Vascular Access System (Pvas)Dermaport, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK091760 Dermaport Ported Vascular Access System (Pvas)Dermaport, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K013160 | Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter | Spire Biomedical, Inc. | 2002 | — |
| −3 | K021212 | 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated… | Spire Biomedical, Inc. | 2002 | — |
| −2 | K022000 | Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips… | Spire Biomedical, Inc. | 2002 | — |
| −1 | K043292 | Hemocath | Med-Conduit, Inc. | 2005 | — |
| 0 (this device) | K062901 | Hemocath II | Med-Conduit, Inc. | 2007 | — |
| +1 | K071202 | Dermaport Percutaneous Vascular Access System (Pvas) | Dermaport, Inc. | 2007 | — |
| +2 | 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 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K043292 | HemocathSummary page 1…ication Name: Long-Term Intravascular Catheter Classification: 78 MSD 3. PREDICATE DEVICES HEMOCATH-SKIN PORT 510 (K) K(043292 4. DEVICE DESCRIPTION The HemoCath II is radiopaque silicone, comprised of 2 single lumens used to r… | 2005 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071202 | Dermaport Percutaneous Vascular Access System (Pvas) | 2007 | 1 |
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 2 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K071202 (Dermaport, Inc., 2007) has gone furthest, with 1 descendant of its own.
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 HemoCath Hemodialysis/Apheresis Catheter is indicated for use in attaining long term vascular access for hemodialysis or apheresis therapy via the jugular or subclavian vein. The catheter is intended for implantation dwell time of greater than 30 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062901 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062901: Hemocath II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062901
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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