510(k) · Cleared
ClearedInstrumed Vessel Dilators, Model 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumed International, Inc. · DWP Dilator, Vessel, Surgical
Cleared on Aug 31, 2010 as substantially equivalent to K030788 (Geister Medizin Technik GmbH, 2003) after a 189-day review. Its family tree reaches back 1 generation to 2003. 3 later devices descend from it.
- Decided
- Aug 31, 2010
- Review
- 189 days
- Class
- Class II
- Product code
- DWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030788 (2003). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK030788 Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel…Geister Medizin Technik GmbH · 2003
- This deviceK100518 Instrumed Vessel Dilators, Model…Instrumed International, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK183438 Geomed Vascular DilatorsGeomed Medizin-Technik GmbH & Co. · 2019
- Descendant · 2 generations on · 0 of its ownK220981 SUPERPLAST Double-Occluder, SUPERPLAST Vascular ProbeFehling Surgical Instruments, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK163524 Vessel DilatorFetzer Medical GmbH & Co. KG · 2017
Most influential descendants
Showing 3 of 3 · See all- K183438Geomed Vascular DilatorsGeomed Medizin-Technik GmbH & Co. · 2019 · cites it directly1descendant
- K220981SUPERPLAST Double-Occluder, SUPERPLAST Vascular ProbeFehling Surgical Instruments, Inc. · 2023 · 2 generations on0descendants
- K163524Vessel DilatorFetzer Medical GmbH & Co. KG · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030788 | Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel Dilators | Geister Medizin Technik GmbH | 2003 | — |
| 0 (this device) | K100518 | Instrumed Vessel Dilators, Model 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 | Instrumed International, Inc. | 2010 | — |
| +1 | K183438 | Geomed Vascular Dilators | Geomed Medizin-Technik GmbH & Co. | 2019 | — |
| +2 | K220981 | SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe | Fehling Surgical Instruments, Inc. | 2023 | — |
| +1 | K163524 | Vessel Dilator | Fetzer Medical GmbH & Co. KG | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 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? (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 |
|---|---|---|---|
| * | K030788 | Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel DilatorsSummary page 1…Code DWP Regulation Description A surgical vessel dilator is a device used to enlarge or calibrate a vessel. Substantial Equivalence Claims: K030788 KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS Applicant GEISTER MED… | 2003 |
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?
How does its category compare?
All DWP devicesDWP Dilator, Vessel, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
INSTRUMED Vessel Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to Perform various manoeuvres of dilation and measurement of annulus and lumen diameters
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100518 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100518: Instrumed Vessel Dilators, Model 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100518
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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