510(k) · Cleared
Recalled · Class II · 2026Coaxial Dilator Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xentek Medical, Inc. · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Aug 1, 2000 after a 147-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it. It has been recalled 5 times.
- Decided
- Aug 1, 2000
- Review
- 147 days
- Class
- Class II
- Product code
- DRE
- Recalls
- 5
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK000737 Coaxial Dilator SetXentek Medical, Inc. · 2000
- Descendant · cites it directly · 2 of its ownK062627 Innerchange Micro-Introducer Catheter, Models 7900 Through 7905Vascular Solutions, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK172487 Coaxial Dilator Set (Micro-Introducer)Galt Medical Corp. · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK073585 Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902…Vascular Solutions, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK071330 Galtstick Introducer SystemGalt Medical Corp. · 2007
- Descendant · 2 generations on · 0 of its ownK192195 Sterile DilatorGalt Medical Corp. · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K062627Innerchange Micro-Introducer Catheter, Models 7900 Through 7905Vascular Solutions, Inc. · 2007 · cites it directly2descendants
- K172487Coaxial Dilator Set (Micro-Introducer)Galt Medical Corp. · 2017 · cites it directly1descendant
- K073585Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and 7905Vascular Solutions, Inc. · 2008 · 2 generations on1descendant
- K071330Galtstick Introducer SystemGalt Medical Corp. · 2007 · cites it directly1descendant
- K192195Sterile DilatorGalt Medical Corp. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000737 | Coaxial Dilator Set | Xentek Medical, Inc. | 2000 | — |
| +1 | K062627 | Innerchange Micro-Introducer Catheter, Models 7900 Through 7905 | Vascular Solutions, Inc. | 2007 | — |
| +1 | K172487 | Coaxial Dilator Set (Micro-Introducer) | Galt Medical Corp. | 2017 | 2 |
| +2 | K073585 | Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and… | Vascular Solutions, Inc. | 2008 | — |
| +1 | K071330 | Galtstick Introducer System | Galt Medical Corp. | 2007 | — |
| +2 | K192195 | Sterile Dilator | Galt Medical Corp. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2026 | Class II | Z-2917-2026 | Under Investigation by firm | Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits. |
| Mar 27, 2025 | Class II | Z-1732-2025 | Process control | Due to a potential open seal in the sterile barrier packaging . |
| May 2, 2018 | Class II | Z-2561-2018 | Other | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce… |
| May 2, 2018 | Class II | Z-2564-2018 | Other | The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also called pyrogenic bacteria can activate the inflammatory process and produce… |
| Feb 8, 2010 | Not classified | Z-1592-2010 | Packaging process control | Potential problem with pouch seal thus affecting sterile product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K062627 (Vascular Solutions, Inc., 2007) has gone furthest, with 2 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/K000737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000737: Coaxial Dilator Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000737
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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