510(k) · Cleared
ClearedVessel Dilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fetzer Medical GmbH & Co. KG · DWP Dilator, Vessel, Surgical
Cleared on Jun 29, 2017 as substantially equivalent to K100518 (Instrumed International, Inc., 2010) and 1 other predicate after a 196-day review. Its family tree reaches back 2 generations to 2003.
- Decided
- Jun 29, 2017
- Review
- 196 days
- Class
- Class II
- Product code
- DWP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K030788 (2003). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K030788 | Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel Dilators | Geister Medizin Technik GmbH | 2003 | — |
| −1 | K100518 | Instrumed Vessel Dilators, Model 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 | Instrumed International, Inc. | 2010 | — |
| 0 (this device) | K163524 | Vessel Dilator | Fetzer Medical GmbH & Co. KG | 2017 | — |
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 DWP? 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 DWP device
- #1 K220981 SUPERPLAST Double-Occluder, SUPERPLAST…score 5.8 · 3 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K100518 | Instrumed Vessel Dilators, Model 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054Summary page 4…umed Vessel Dilators Geister Garrett, Cooley and Debakey Vessel Dilators 510(k) No. K100518 K030788 510(k) submitter / INSTRUMED INTERNATIONAL, INC. Geister Medizintechnik GmbH… | 2010 |
| * | K030788 | Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel DilatorsSummary page 4…er Garrett, Cooley and Debakey Vessel Dilators 510(k) No. K100518 K030788 510(k) submitter / INSTRUMED INTERNATIONAL, INC. Geister Medizintechnik GmbH holder 626 Cooper Court… | 2003 |
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 14 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K100518.
How does its category compare?
All DWP devicesDWP Dilator, Vessel, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DWP
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DWP
Too few DWP 510(k)s in any year since 2007 to give a median.
Recalls per year · DWP
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWP
1in 2022
MAUDE reports naming product code DWP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 13 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 25 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 1 | — | 0 | 34 |
| 2018 | 0 | — | 0 | 29 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Fetzer Medical vessel dilators are devices used to enlarge or calibrate a vessel during cardiovascular surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163524: Vessel Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163524
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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