510(k) · Cleared
ClearedDatascope Proguide Chronic Dialysis Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datascope Corp. · MSD Catheter, Hemodialysis, Implanted
Cleared on Sep 23, 2004 as substantially equivalent to K994105 (Medical Components, Inc., 2001) after a 58-day review. Its family tree reaches back 2 generations to 1998. 1 of the 4 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Sep 23, 2004
- Review
- 58 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972207 (1998). 1 later device descends from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK972207 Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CMMedcomp · 1998
- 1 generation backK994105 Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32…Medical Components, Inc. · 2001 · Recalled
- This deviceK042016 Datascope Proguide Chronic Dialysis CatheterDatascope Corp. · 2004
- Descendant · cites it directly · 0 of its ownK090148 Proguide Chronic Dialysis CatheterMerit Medical Systems, Inc. · 2009 · Recalled (Class I)
Class I recalls in this family
- K090148 Proguide Chronic Dialysis Cathetercites it directly · 2009
Most influential descendants
Showing 1 of 1 · See all- K090148Proguide Chronic Dialysis CatheterMerit Medical Systems, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972207 | Medcomp Ash Split-Cath 28CM, Medcomp Ash Split-Cath 32CM | Medcomp | 1998 | — |
| −1 | K994105 | Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 | Medical Components, Inc. | 2001 | 2 |
| 0 (this device) | K042016 | Datascope Proguide Chronic Dialysis Catheter | Datascope Corp. | 2004 | — |
| +1 | K090148 | Proguide Chronic Dialysis Catheter | Merit Medical Systems, Inc. | 2009 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has 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 |
|---|---|---|---|
| * | K994105 | Hemo-Flow Double Lumen Catheter, Models HFS-24, HFS-28, HFS-32, HFS-36, HFS-40Summary page 1…Classification: 78 MSD C.F.R. Section: 876.5540 C. Predicate Device: K994105 Medcomp Hemo-FlowTM Catheter D. Device Description: The Datascope Chronic Dialysis Catheter is double lumen polyurethane… | 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 |
|---|---|---|---|
| K090148 | Proguide Chronic Dialysis Catheter Class I | 2009 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · Cites it directly · ◆ in the 2009 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K090148 (Merit Medical Systems, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K994105.
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 Datascope Chronic Dialysis catheter is indicated for use in attaining long-term access for hemodialysis and apheresis.
It may be implanted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
Alternate insertion sites include the subclavian vein as required.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042016: Datascope Proguide Chronic Dialysis Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042016
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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