510(k) · Cleared
ClearedKamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel Dilators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geister Medizin Technik GmbH · DWP Dilator, Vessel, Surgical
Cleared on Jul 12, 2003 after a 122-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jul 12, 2003
- Review
- 122 days
- Class
- Class II
- Product code
- DWP
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK030788 Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel…Geister Medizin Technik GmbH · 2003
- Descendant · cites it directly · 3 of its ownK100518 Instrumed Vessel Dilators, Model…Instrumed International, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK183438 Geomed Vascular DilatorsGeomed Medizin-Technik GmbH & Co. · 2019
- Descendant · 3 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
- Descendant · cites it directly · 0 of its ownK131446 Integra Jarit Heparin Cannulas, Injectors, and NeedlesIntegra LifeSciences Corporation · 2013
Most influential descendants
Showing 5 of 5 · See all- K100518Instrumed Vessel Dilators, Model 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054Instrumed International, Inc. · 2010 · cites it directly3descendants
- K183438Geomed Vascular DilatorsGeomed Medizin-Technik GmbH & Co. · 2019 · 2 generations on1descendant
- K220981SUPERPLAST Double-Occluder, SUPERPLAST Vascular ProbeFehling Surgical Instruments, Inc. · 2023 · 3 generations on0descendants
- K163524Vessel DilatorFetzer Medical GmbH & Co. KG · 2017 · cites it directly0descendants
- K131446Integra Jarit Heparin Cannulas, Injectors, and NeedlesIntegra LifeSciences Corporation · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K183438 | Geomed Vascular Dilators | Geomed Medizin-Technik GmbH & Co. | 2019 | — |
| +3 | K220981 | SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe | Fehling Surgical Instruments, Inc. | 2023 | — |
| +1 | K163524 | Vessel Dilator | Fetzer Medical GmbH & Co. KG | 2017 | — |
| +1 | K131446 | Integra Jarit Heparin Cannulas, Injectors, and Needles | Integra LifeSciences Corporation | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
3 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?
- Of its descendants, K100518 (Instrumed International, Inc., 2010) has gone furthest, with 3 descendants of its own.
How does its category compare?
All DWP devicesDWP Dilator, Vessel, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
GEISTER vessel dilators are devices used to enlarge or calibrate vessels during coronary artcry bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K030788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030788: Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel Dilators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030788
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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