510(k) · Decided
DecidedGamcath High Flow Catheter, Ref: GDHK 13XX a
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Renal Products · MPB Catheter, Hemodialysis, Non-Implanted
Cleared on Nov 1, 2004 as substantially equivalent to K010778 (C.R. Bard, Inc., 2001) after a 266-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.
- Decided
- Nov 1, 2004
- Review
- 266 days
- Class
- Class II
- Product code
- MPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010778 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK010778 Niagara Slim-CathC.R. Bard, Inc. · 2001
- This deviceK040301 Gamcath High Flow Catheter, Ref: GDHK 13XX aGambro Renal Products · 2004
- Descendant · cites it directly · 0 of its ownK100451 Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a…Gambro Renal Products, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K100451Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a, Gamcath High Flow Dolphin…Gambro Renal Products, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010778 | Niagara Slim-Cath | C.R. Bard, Inc. | 2001 | — |
| 0 (this device) | K040301 | Gamcath High Flow Catheter, Ref: GDHK 13XX a | Gambro Renal Products | 2004 | — |
| +1 | K100451 | Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a, Gamcath High… | Gambro Renal Products, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 MPB? 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 MPB device
- #1 K250836 14F Duo-Flow® Side X Side Double Lumen Catheterscore 10.1 · 2 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 |
|---|---|---|---|
| * | K010778 | Niagara Slim-CathSummary page 1…Straight: 12 French, 15, 20 and 24 cm Precurved: 12 French, 12.5, 15 and 20 cm K010778; April 13, 2001 DEVICE DESCRIPTION: The catheter is a device, which can be used for short-term (less than 30 days) vascular acc… | 2001 |
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 |
|---|---|---|---|
| K100451 | Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a, Gamcath High Flow Dolphin… | 2010 | 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?
How does its category compare?
All MPB devicesMPB Catheter, Hemodialysis, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MPB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MPB
205in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MPB
4so far in 2026, the most since 2007
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · MPB
187in 2025
MAUDE reports naming product code MPB, 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 | 3 | 136 | 1 | 41 |
| 2008 | 0 | — | 0 | 147 |
| 2009 | 1 | — | 0 | 166 |
| 2010 | 1 | — | 0 | 60 |
| 2011 | 2 | — | 0 | 74 |
| 2012 | 1 | — | 0 | 78 |
| 2013 | 1 | — | 0 | 124 |
| 2014 | 0 | — | 0 | 82 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 1 | — | 0 | 70 |
| 2017 | 2 | — | 2 | 86 |
| 2018 | 0 | — | 0 | 120 |
| 2019 | 0 | — | 0 | 119 |
| 2020 | 3 | 205 | 0 | 179 |
| 2021 | 0 | — | 0 | 192 |
| 2022 | 0 | — | 0 | 166 |
| 2023 | 0 | — | 0 | 203 |
| 2024 | 0 | — | 0 | 181 |
| 2025 | 1 | — | 0 | 187 |
| 2026 | 0 | — | 4 (3) | — |
What is it indicated for?
GamCath® catheters are indicated for use in attaining short-term vascular access for
hemodialysis, hemoperfusion and apheresis therapy via the jugular, subclavian or femoral vein.
Not for pediatric use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040301 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040301: Gamcath High Flow Catheter, Ref: GDHK 13XX a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040301
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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