510(k) · Cleared
Recalled · Class II · 2020Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Components, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Oct 3, 2001 as substantially equivalent to K972207 (Medcomp, 1998) after a 667-day review. Its family tree reaches back 1 generation to 1998. 4 of the 22 devices in its family, counting itself, have a Class I recall. 20 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 3, 2001
- Review
- 667 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972207 (1998). 20 later devices descend from it, 6 citing it directly. 4 of the 22 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK972207 Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CMMedcomp · 1998
- This deviceK994105 Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32…Medical Components, Inc. · 2001
- Descendant · cites it directly · 13 of its ownK030502 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55Medcomp · 2003 · Recalled
- Descendant · 2 generations on · 8 of its ownK040992 15F X 55CM Excell Split -Tip Catheter, Models 10300606, 10300706Medcomp · 2004
- Descendant · 3 generations on · 7 of its ownK070572 Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X…Ash Access Technology, Inc. · 2007 · Recalled
- Descendant · cites it directly · 6 of its ownK080400 Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2008 · Recalled
- Descendant · cites it directly · 4 of its ownK121933 Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD…Marvao Medical Devices, Ltd. · 2013
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 20 · See all- K03050214.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55Medcomp · 2003 · cites it directly13descendants
- K04099215F X 55CM Excell Split -Tip Catheter, Models 10300606, 10300706Medcomp · 2004 · 2 generations on8descendants
- K070572Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR X 28CM…Ash Access Technology, Inc. · 2007 · 3 generations on7descendants
- K080400Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2008 · cites it directly6descendants
- K121933Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD Hemodialysis…Marvao Medical Devices, Ltd. · 2013 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972207 | Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CM | Medcomp | 1998 | — |
| 0 (this device) | K994105 | Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 | Medical Components, Inc. | 2001 | — |
| +1 | K030502 | 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55 | Medcomp | 2003 | 2 |
| +2 | K040992 | 15F X 55CM Excell Split -Tip Catheter, Models 10300606, 10300706 | Medcomp | 2004 | — |
| +3 | K070572 | Ash Advance Hemodialysis Catheter and Procedure Kit, Models; 15FR X 24CM, 15FR… | Ash Access Technology, Inc. | 2007 | 3 |
| +1 | K080400 | Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure Kit | AngioDynamics, Inc. | 2008 | 5 |
| +1 | K121933 | Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD… | Marvao Medical Devices, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 1 |
| 2010 | 1 | 1 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 1 |
| 2016 | 2 | 1 |
| 2018 | 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.
4 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K972207 | Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CMSummary page 1…tober 29, 1999 " Trade Name: Medcomp Hemo-Flow Catheter Common Name: Hemodialysis Catheter, Implanted Classification: 78 MSD C.F.R. Section: 876.5540 Predicate Device: K972207 Medcomp Ash Split-Cath Device Description: The Medcomp Hemo-Flow Catheter is a polyurethane, double lumen catheter used to remo… | 1998 |
What descends from it? (20)
See all 206 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030502 | 14.5F X 55CM Hemo-Flow Double Lumen Catheter, Models HFS-55, HFT-55 | 2003 | 13 |
| K080400 | Angiodynamics, Inc., Duramax Hemodialysis Catheter and Procedure Kit | 2008 | 6 |
| K121933 | Nexsite HD Hemodialysis Catheter for Long Term Use (28CM) Nexsite HD Hemodialysis… | 2013 | 4 |
| K071202 | Dermaport Percutaneous Vascular Access System (Pvas) | 2007 | 1 |
| K042016 | Datascope Proguide Chronic Dialysis Catheter | 2004 | 1 |
| K072499 | Novoflo Catheter LT | 2007 | 0 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 27, 2020 | Class II | Z-2940-2020 | Under Investigation by firm | Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer |
| Feb 5, 2015 | Class II | Z-1351-2015 | Process control | Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III because the product shipped was out of specification. One BI… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K090148Proguide Chronic Dialysis CatheterMerit Medical Systems, Inc. · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
- K101843Duramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K151967Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis CatheterMerit Medical Systems, Inc. · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 Medcomp Hemo-Flow Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site includes the subclavian vein as required.
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/K994105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994105: Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994105
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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