510(k) · Cleared
ClearedProtekDilate Vascular Access Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Italia S.R.L. · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Dec 19, 2025 as substantially equivalent to K162181 (Cardiacassist, Inc., 2017) after a 31-day review. Its family tree reaches back 5 generations to 1989.
- Decided
- Dec 19, 2025
- Review
- 31 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K891022 (1989). No later device cites it as a predicate yet.
- Root · 5 generations backK891022 Introducer for Ptca Guiding CathetersArgon Medical Corp. · 1989
- 4 generations backK963388 Vessel DilatorMaxxim Medical · 1997
- 3 generations backK070749 Estech Percutaneous Insertion Dilator KitCoombs Medical Device Consulting · 2007
- 2 generations backK081940 Avalon Elite Vascular Access KitAvalon Laboratories, LLC · 2008 · Recalled
- 1 generation backK162181 Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetCardiacassist, Inc. · 2017 · Recalled
- This deviceK253616 ProtekDilate Vascular Access KitSorin Group Italia S.R.L. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K891022 | Introducer for Ptca Guiding Catheters | Argon Medical Corp. | 1989 | — |
| −4 | K963388 | Vessel Dilator | Maxxim Medical | 1997 | — |
| −3 | K070749 | Estech Percutaneous Insertion Dilator Kit | Coombs Medical Device Consulting | 2007 | — |
| −2 | K081940 | Avalon Elite Vascular Access Kit | Avalon Laboratories, LLC | 2008 | 1 |
| −1 | K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set | Cardiacassist, Inc. | 2017 | 1 |
| 0 (this device) | K253616 | ProtekDilate Vascular Access Kit | Sorin Group Italia S.R.L. | 2025 | — |
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 |
|---|---|---|---|
| * | K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetSummary page 6…e and predicate device have the same fundamental scientific technology and intended use: Predicate Device 510(k) Number: K162181 Device Trade Name: ProtekDuo Venous Dilator Set (14 Fr… | 2017 |
| † | K182914 | MC3 Vascular Access Kit 21030 | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 36 years and passes through 6 companies; a new generation was cleared every 8.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
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. 2025, this device’s year, is highlighted.
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 ProtekDilate Vascular Access Kits are intended for single use by a trained physician to assist in vessel cannulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253616 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253616: ProtekDilate Vascular Access Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253616
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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