510(k) · Cleared
ClearedVessel Dilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datascope Corp. · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Dec 10, 1990 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 19 devices in its family, counting itself, have a Class I recall. 18 later devices descend from it.
- Decided
- Dec 10, 1990
- Review
- 70 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 1 citing it directly. 5 of the 19 devices in this family, counting this one, have a Class I recall.
- This deviceK904476 Vessel DilatorDatascope Corp. · 1990
- Descendant · cites it directly · 17 of its ownK980385 Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters…Datascope Corp. · 1998
- Descendant · 2 generations on · 15 of its ownK994157 Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories…Datascope Corp. · 2000
- Descendant · 3 generations on · 14 of its ownK013326 Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC…Datascope Corp. · 2001
- Descendant · 4 generations on · 12 of its ownK031569 Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003
- Descendant · 4 generations on · 11 of its ownK041281 Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 18 · See all- K980385Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional…Datascope Corp. · 1998 · cites it directly17descendants
- K994157Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models 0684-00-0327…Datascope Corp. · 2000 · 2 generations on15descendants
- K013326Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC, Datascope…Datascope Corp. · 2001 · 3 generations on14descendants
- K031569Datascope CA 40 8FR. Iabs, Model 0684-00-04XXDatascope Corp. · 2003 · 4 generations on12descendants
- K041281Datascope 7.5FR. Iab Catheter and AccessoriesDatascope Corp. · 2004 · 4 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904476 | Vessel Dilator | Datascope Corp. | 1990 | — |
| +1 | K980385 | Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for… | Datascope Corp. | 1998 | — |
| +2 | K994157 | Datascope's 8FR. Polymide 25CC,34CC and 40CC Iab and Accessories, Models… | Datascope Corp. | 2000 | — |
| +3 | K013326 | Modification to: Datascope 8FR. Polyimide Alt B Iab, 25CC, 34CC, 40CC… | Datascope Corp. | 2001 | — |
| +4 | K031569 | Datascope CA 40 8FR. Iabs, Model 0684-00-04XX | Datascope Corp. | 2003 | — |
| +4 | K041281 | Datascope 7.5FR. Iab Catheter and Accessories | Datascope Corp. | 2004 | 7 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 1 |
| 2009 | 2 | 0 |
| 2011 | 2 | 1 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 1 |
| 2017 | 2 | 1 |
| 2018 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
5 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 DRE device
- #1 K261310 FlexTract Deflectable-Rotational Dilator…score 12.0 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980385 | Datascope 8FR. CO-Lumen 34 and 40CC Intra-Aortic Balloon Catheters for Optional… | 1998 | 17 |
Has anything in its family been recalled? (5 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.
- K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300 Intra-Aortic Balloon Pump…Datascope Corp. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 110 Class I recalls
- K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp. · 2018 · 6 generations on · ◆ in the 2018 descendants bar of FIG. 127 Class I recalls
- K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp. · 2015 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 112 Class I recalls
- K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp. · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
What does this lineage say?
- Of its descendants, K980385 (Datascope Corp., 1998) has gone furthest, with 17 descendants of its own.
How does its category compare?
All DRE devicesDRE Dilator, Vessel, For Percutaneous Catheterization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRE
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRE
1in 2016
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DRE
356in 2025
MAUDE reports naming product code DRE, 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 | 5 | 160 | 0 | 81 |
| 2008 | 2 | — | 0 | 38 |
| 2009 | 2 | — | 2 | 69 |
| 2010 | 1 | — | 2 | 73 |
| 2011 | 1 | — | 1 | 90 |
| 2012 | 1 | — | 0 | 132 |
| 2013 | 4 | 111 | 0 | 120 |
| 2014 | 6 | 72 | 0 | 82 |
| 2015 | 4 | 30 | 1 | 82 |
| 2016 | 3 | 90 | 1 | 84 |
| 2017 | 4 | 108 | 0 | 101 |
| 2018 | 2 | — | 0 | 126 |
| 2019 | 3 | 68 | 0 | 144 |
| 2020 | 3 | 30 | 0 | 120 |
| 2021 | 1 | — | 0 | 115 |
| 2022 | 3 | 261 | 0 | 136 |
| 2023 | 2 | — | 0 | 386 |
| 2024 | 1 | — | 0 | 325 |
| 2025 | 3 | 31 | 0 | 356 |
| 2026 | 1 | — | 1 (1) | — |
https://510kreport.com/device/K904476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K904476: Vessel Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904476
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026