510(k) · Cleared
Recalled · Class II · 2021Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiacassist, Inc. · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Jan 6, 2017 as substantially equivalent to K081940 (Avalon Laboratories, LLC, 2008) after a 155-day review. Its family tree reaches back 4 generations to 1989. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 6, 2017
- Review
- 155 days
- Class
- Class II
- Product code
- DRE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K891022 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK891022 Introducer for Ptca Guiding CathetersArgon Medical Corp. · 1989
- 3 generations backK963388 Vessel DilatorMaxxim Medical · 1997
- 2 generations backK070749 Estech Percutaneous Insertion Dilator KitCoombs Medical Device Consulting · 2007
- 1 generation backK081940 Avalon Elite Vascular Access KitAvalon Laboratories, LLC · 2008 · Recalled
- This deviceK162181 Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetCardiacassist, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK253616 ProtekDilate Vascular Access KitSorin Group Italia S.R.L. · 2025
Most influential descendants
Showing 1 of 1 · See all- K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K891022 | Introducer for Ptca Guiding Catheters | Argon Medical Corp. | 1989 | — |
| −3 | K963388 | Vessel Dilator | Maxxim Medical | 1997 | — |
| −2 | K070749 | Estech Percutaneous Insertion Dilator Kit | Coombs Medical Device Consulting | 2007 | — |
| −1 | K081940 | Avalon Elite Vascular Access Kit | Avalon Laboratories, LLC | 2008 | 1 |
| 0 (this device) | K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set | Cardiacassist, Inc. | 2017 | — |
| +1 | K253616 | ProtekDilate Vascular Access Kit | Sorin Group Italia S.R.L. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K081940 | Avalon Elite Vascular Access KitSummary page 4…Vessel dilator for percutaneous catheterization (21 CFR 870.1310, Product Code DRE) Predicate Devices Avalon Elite Vascular Access Kit (K081940) Device Description The Protek Venous Dilator Sets are comprised of vascular dilators with diameters of 14,… | 2008 |
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 |
|---|---|---|---|
| K253616 | ProtekDilate Vascular Access Kit | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 19, 2021 | Class II | Z-1486-2021 | Under Investigation by firm | On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had been distributed to the field. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 8.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K253616 (Sorin Group Italia S.R.L., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K081940.
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. 2017, 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 Protek Venous Dilator Sets 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/K162181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162181: Protek Duo Venous Dilator Set, Protek Solo Venous 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/K162181
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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