510(k) · Cleared
ClearedMedcomp Vessel Dilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcomp ( Medical Components) · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Jun 1, 2017 as substantially equivalent to K801113 (Alva Medical, Inc., 1980) after a 279-day review. Its family tree reaches back 1 generation to 1980. 3 later devices descend from it.
- Decided
- Jun 1, 2017
- Review
- 279 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K801113 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK801113 Dilator, Vessel, for Perc. Catheter.Alva Medical, Inc. · 1980
- This deviceK162389 Medcomp Vessel DilatorMedcomp ( Medical Components) · 2017
- Descendant · cites it directly · 1 of its ownK183036 Dilator SetsCook Incorporated · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK210734 Endovascular Dilator and SetsCook Incorporated · 2021
- Descendant · cites it directly · 0 of its ownK192283 MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel…Medron, LLC · 2020
Most influential descendants
Showing 3 of 3 · See all- K183036Dilator SetsCook Incorporated · 2018 · cites it directly1descendant
- K210734Endovascular Dilator and SetsCook Incorporated · 2021 · 2 generations on0descendants
- K192283MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F…Medron, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K801113 | Dilator, Vessel, for Perc. Catheter. | Alva Medical, Inc. | 1980 | — |
| 0 (this device) | K162389 | Medcomp Vessel Dilator | Medcomp ( Medical Components) | 2017 | — |
| +1 | K183036 | Dilator Sets | Cook Incorporated | 2018 | 3 |
| +2 | K210734 | Endovascular Dilator and Sets | Cook Incorporated | 2021 | — |
| +1 | K192283 | MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F… | Medron, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K801113 | Dilator, Vessel, for Perc. Catheter.Summary page 4…Vessel Ditator Vessel Dilator Ditator, Vessel, for Percutaneous Catheterization DRE Vessel Dilator for percutaneous catheterization 21 CFR 870.1310 Cardiovascular K801113 Merit® Medical Percutaneous Vessel Ditator Dilator 6-1 ' ‘ Medcomp® Vessal Dilator Device: Ditator, Vessel for… | 1980 |
What descends from it? (3)
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, K183036 (Cook Incorporated, 2018) has gone furthest, with 1 descendant 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. 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 Medcomp Vessel Dilators are designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter in a vein or artery.
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/K162389 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162389: Medcomp Vessel Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162389
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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