510(k) · Cleared
ClearedGelbish Vascular Dilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascumetrix, LLC · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Dec 20, 2001 as substantially equivalent to K974617 (Endovascular Instruments, Inc., 1998) after a 155-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Dec 20, 2001
- Review
- 155 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974617 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK974617 Peripheral Vascular DilatorEndovascular Instruments, Inc. · 1998
- This deviceK012256 Gelbish Vascular DilatorVascumetrix, LLC · 2001
- Descendant · cites it directly · 0 of its ownK030260 Gelbfish Flex Vascular DilatorVascumetrix, LLC · 2003
- Descendant · cites it directly · 0 of its ownK023507 Modification to Gelbfish Vascular DilatorsVascumetrix, LLC · 2002
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974617 | Peripheral Vascular Dilator | Endovascular Instruments, Inc. | 1998 | — |
| 0 (this device) | K012256 | Gelbish Vascular Dilator | Vascumetrix, LLC | 2001 | — |
| +1 | K030260 | Gelbfish Flex Vascular Dilator | Vascumetrix, LLC | 2003 | — |
| +1 | K023507 | Modification to Gelbfish Vascular Dilators | Vascumetrix, LLC | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 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 DRE? 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? (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 |
|---|---|---|---|
| * | K974617 | Peripheral Vascular DilatorSummary page 2…: The VascuMetrix Gelbfish™ Vascular Dilators are to be used over a guidewire to dilate or calibrate blood vessels. 1.5 Predicate Device 510(k) Number: K974617 Device Name: Peripheral Vascular Dilator Manufacturer: EndoVascular Instruments, Inc. Common/Generic Name: DILATOR, VESSEL, FO… | 1998 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K030260 (Vascumetrix, LLC, 2003) has gone furthest, with 0 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) | — |
What is it indicated for?
The VascuMetrix Gelbfish™ Vascular Dilators are to be used over a guidewire to
dilate or calibrate blood vessels.
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/K012256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012256: Gelbish Vascular Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012256
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026