510(k) · Cleared
ClearedVessel Dilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maxxim Medical · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Mar 11, 1997 as substantially equivalent to K891022 (Argon Medical Corp., 1989) after a 195-day review. Its family tree reaches back 1 generation to 1989. 11 later devices descend from it.
- Decided
- Mar 11, 1997
- Review
- 195 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K891022 (1989). 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK891022 Introducer for Ptca Guiding CathetersArgon Medical Corp. · 1989
- This deviceK963388 Vessel DilatorMaxxim Medical · 1997
- Descendant · cites it directly · 10 of its ownK070749 Estech Percutaneous Insertion Dilator KitCoombs Medical Device Consulting · 2007
- Descendant · 2 generations on · 4 of its ownK081940 Avalon Elite Vascular Access KitAvalon Laboratories, LLC · 2008 · Recalled
- Descendant · cites it directly · 2 of its ownK093554 Retroflex Dilator KitEdwards Lifesciences, LLC · 2010
- Descendant · 3 generations on · 1 of its ownK162181 Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetCardiacassist, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK123842 Lawmax DilatorLifetech Scientific (Shenzhen) Co., Ltd. · 2013
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K070749Estech Percutaneous Insertion Dilator KitCoombs Medical Device Consulting · 2007 · cites it directly10descendants
- K081940Avalon Elite Vascular Access KitAvalon Laboratories, LLC · 2008 · 2 generations on4descendants
- K093554Retroflex Dilator KitEdwards Lifesciences, LLC · 2010 · cites it directly2descendants
- K162181Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetCardiacassist, Inc. · 2017 · 3 generations on1descendant
- K123842Lawmax DilatorLifetech Scientific (Shenzhen) Co., Ltd. · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891022 | Introducer for Ptca Guiding Catheters | Argon Medical Corp. | 1989 | — |
| 0 (this device) | K963388 | Vessel Dilator | Maxxim Medical | 1997 | — |
| +1 | K070749 | Estech Percutaneous Insertion Dilator Kit | Coombs Medical Device Consulting | 2007 | — |
| +2 | K081940 | Avalon Elite Vascular Access Kit | Avalon Laboratories, LLC | 2008 | 1 |
| +1 | K093554 | Retroflex Dilator Kit | Edwards Lifesciences, LLC | 2010 | — |
| +3 | K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set | Cardiacassist, Inc. | 2017 | 1 |
| +2 | K123842 | Lawmax Dilator | Lifetech Scientific (Shenzhen) Co., Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K891022 | Introducer for Ptca Guiding CathetersSummary page 1…essel Dilator Classification Name: Vessel Dilator for percutaneous catheterization PREDICATE DEVICE Vessel Dilator component of Introducer for PTCA Guiding Catheters; K891022; Argon Medical. DEVICE DESCRIPTION The Vessel Dilator is a device used over a guide wire to dilate the opening in a vessel in p… | 1989 |
What descends from it? (11)
See all 112 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, K070749 (Coombs Medical Device Consulting, 2007) has gone furthest, with 10 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?
To enlarge the opening in a vessel in preparation of percutaneous entry of a catheter.
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/K963388 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963388: Vessel Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963388
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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