510(k) · Cleared
ClearedSoft-Cell Dual Lumen Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Aug 6, 2003 as substantially equivalent to K871488 (Vas-Cath of Canada, Ltd., 1987) after a 191-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Aug 6, 2003
- Review
- 191 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K871488 (1987). No later device cites it as a predicate yet.
- Root · 1 generation backK871488 Vas-Cath Permanent Dual Lumen Hemodialysis CathVas-Cath of Canada, Ltd. · 1987
- This deviceK030277 Soft-Cell Dual Lumen CathetersC.R. Bard, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871488 | Vas-Cath Permanent Dual Lumen Hemodialysis Cath | Vas-Cath of Canada, Ltd. | 1987 | — |
| 0 (this device) | K030277 | Soft-Cell Dual Lumen Catheters | C.R. Bard, Inc. | 2003 | — |
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 |
|---|---|---|---|
| * | K871488 | Vas-Cath Permanent Dual Lumen Hemodialysis CathSummary page 1…or premai-ket approval for the device described in paragraph (b)( 1). Predicate Device: (As described above) Soft-Cell Dual Lumen Catheter K871488 Summary of Change: The modification to the Short-Term Dialysis Catheters is a change of material and design for the h e r… | 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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K871488.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Vas-Cath Soft-Cell dual lumen hemodialysis catheter is indicated for use in attaining short term or long term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular or subclavian vein.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030277 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030277: Soft-Cell Dual Lumen Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030277
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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