510(k) · Cleared
ClearedGamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a, Gamcath High Flow Dolphin MS-GDHC-1320 a; and MS-GDHC-132
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gambro Renal Products, Inc. · MPB Catheter, Hemodialysis, Non-Implanted
Cleared on Dec 21, 2010 as substantially equivalent to K040301 (Gambro Renal Products, 2004) and 1 other predicate after a 307-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Dec 21, 2010
- Review
- 307 days
- Class
- Class II
- Product code
- MPB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K974236 (1999). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK974236 Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146…Medical Components, Inc. · 1999
- 1 generation backK991320 Medcomp Duo-Flow II Catheter with Lubricious HeparinMedical Components, Inc. · 1999
- This deviceK100451 Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a…Gambro Renal Products, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974236 | Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon… | Medical Components, Inc. | 1999 | — |
| −1 | K991320 | Medcomp Duo-Flow II Catheter with Lubricious Heparin | Medical Components, Inc. | 1999 | — |
| 0 (this device) | K100451 | Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a, Gamcath High… | Gambro Renal Products, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K040301 | Gamcath High Flow Catheter, Ref: GDHK 13XX aSummary page 3…AL CHARACTERISTICS COMPARED TO PREDICATE DEVICE The GamnCath® High Flow Dolphin® Catheter is substantially equivalent to the GamCath® High Flow Catheter, K040301 and the MedlComp Duo-Flow If Catheter with Lubricious Heparin manufactured by Medical Components, Inc. K991320.… | 2004 |
| * | K991320 | Medcomp Duo-Flow II Catheter with Lubricious HeparinSummary page 2…Nameof DeiceLubricious te Heparin 510(k) Number K991320 Classification Name Catheter Hemodialysis Non-Implanted Device Class… | 1999 |
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 11 years and passes through 2 companies; a new generation was cleared every 11.1 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All MPB devicesMPB Catheter, Hemodialysis, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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® High Flow Dolphin® catheters are indicated for use in attaining short term vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular, subclavian or femoral vein. GamCath® High Flow Dolphin® Catheter is not intended for use in pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100451: Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a, Gamcath High Flow Dolphin MS-GDHC-1320 a; and MS-GDHC-132.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100451
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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