510(k) · Decided
DecidedVessel Dilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Feb 14, 1984 after a 0-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Feb 14, 1984
- Review
- 0 days
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK840641 Vessel DilatorAries Medical, Inc. · 1984
- Descendant · cites it directly · 0 of its ownK062554 Starclose Hex-Hub DilatorAbbott Vascular, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K062554Starclose Hex-Hub DilatorAbbott Vascular, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K840641 | Vessel Dilator | Aries Medical, Inc. | 1984 | — |
| +1 | K062554 | Starclose Hex-Hub Dilator | Abbott Vascular, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
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.
Planning a device in this category? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062554 | Starclose Hex-Hub Dilator | 2007 | 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?
- Of its descendants, K062554 (Abbott Vascular, Inc., 2007) has gone furthest, with 0 descendants of its own.
https://510kreport.com/device/K840641 · printed Nov 6, 2026
Cite this page
510(k) Report. “K840641: 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/K840641
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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