510(k) · Cleared
ClearedSUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fehling Surgical Instruments, Inc. · DWP Dilator, Vessel, Surgical
Cleared on Apr 20, 2023 as substantially equivalent to K183438 (Geomed Medizin-Technik GmbH & Co., 2019) after a 381-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Apr 20, 2023
- Review
- 381 days
- Class
- Class II
- Product code
- DWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K030788 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backK030788 Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel…Geister Medizin Technik GmbH · 2003
- 2 generations backK100518 Instrumed Vessel Dilators, Model…Instrumed International, Inc. · 2010
- 1 generation backK183438 Geomed Vascular DilatorsGeomed Medizin-Technik GmbH & Co. · 2019
- This deviceK220981 SUPERPLAST Double-Occluder, SUPERPLAST Vascular ProbeFehling Surgical Instruments, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K030788 | Kamar Annulus Dilator + Sizer; Garrett, Cooley, and Debakey Vessel Dilators | Geister Medizin Technik GmbH | 2003 | — |
| −2 | 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 | — |
| 0 (this device) | K220981 | SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe | Fehling Surgical Instruments, Inc. | 2023 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K183438 | Geomed Vascular DilatorsSummary page 4…ation: Class II Reviewing Panel: Cardiovascular Product Code: DWP Predicate Device: Geomed Vascular Dilators (K183438) The predicate device has never been subject to a recall. Device Description: The Fehling SUP… | 2019 |
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 20 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All DWP devicesDWP Dilator, Vessel, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
The Fehling SUPERPLAST Probes are intended to be used to enlarge or calibrate vessels during coronary artery bypass and 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 summary.
https://510kreport.com/device/K220981 · printed Nov 5, 2026
Cite this page
510(k) Report. “K220981: SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K220981
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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