510(k) · Cleared
ClearedSpeedband Superview Super 7, Injection Speedband Superview Super 7, Models 4205 and 4238
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FHN Ligator, Hemorrhoidal
Cleared on Apr 12, 2002 after a 29-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Apr 12, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- FHN
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK020824 Speedband Superview Super 7, Injection Speedband Superview Super 7…Boston Scientific Corp · 2002
- Descendant · cites it directly · 6 of its ownK101428 Otsc (Over-the Scope-Clip) System SetOvesco Endoscopy AG · 2010
- Descendant · 2 generations on · 2 of its ownK120814 Padlock Clip-12Aponos Medical Corp. · 2012 · Recalled
- Descendant · 2 generations on · 1 of its ownK241858 BARS Set (100.60)Ovesco Endoscopy AG · 2024
- Descendant · 3 generations on · 1 of its ownK180689 Padlock Clip defect closure device; Padlock Clip Pro-Select defect…STERIS Corporation · 2018
- Descendant · 3 generations on · 0 of its ownK251562 OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K101428Otsc (Over-the Scope-Clip) System SetOvesco Endoscopy AG · 2010 · cites it directly6descendants
- K120814Padlock Clip-12Aponos Medical Corp. · 2012 · 2 generations on2descendants
- K241858BARS Set (100.60)Ovesco Endoscopy AG · 2024 · 2 generations on1descendant
- K180689Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure deviceSTERIS Corporation · 2018 · 3 generations on1descendant
- K251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020824 | Speedband Superview Super 7, Injection Speedband Superview Super 7, Models… | Boston Scientific Corp | 2002 | — |
| +1 | K101428 | Otsc (Over-the Scope-Clip) System Set | Ovesco Endoscopy AG | 2010 | — |
| +2 | K120814 | Padlock Clip-12 | Aponos Medical Corp. | 2012 | 1 |
| +2 | K241858 | BARS Set (100.60) | Ovesco Endoscopy AG | 2024 | — |
| +3 | K180689 | Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure… | STERIS Corporation | 2018 | — |
| +3 | K251562 | OTSCneo System Set (100.03n-14n, 100.27n-31n) | Ovesco Endoscopy AG | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 FHN? 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 FHN device
- #1 K213223 Multi-Band Ligatorscore 3.5 · 1 generation · 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 |
|---|---|---|---|
| * | — | Modified Injection Speedband™ Superview Named without a submission number | |
| * | — | Modified Speedband™ Superview Named without a submission number |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101428 | Otsc (Over-the Scope-Clip) System Set | 2010 | 6 |
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, K101428 (Ovesco Endoscopy AG, 2010) has gone furthest, with 6 descendants of its own.
How does its category compare?
All FHN devicesFHN Ligator, Hemorrhoidal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FHN
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · FHN
Too few FHN 510(k)s in any year since 2007 to give a median.
Recalls per year · FHN
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FHN
7in 2025
MAUDE reports naming product code FHN, 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 | 1 | — | 0 | 11 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 1 | — | 2 | 3 |
| 2010 | 1 | — | 1 | 17 |
| 2011 | 0 | — | 1 | 9 |
| 2012 | 0 | — | 0 | 11 |
| 2013 | 1 | — | 0 | 102 |
| 2014 | 0 | — | 0 | 208 |
| 2015 | 1 | — | 0 | 228 |
| 2016 | 0 | — | 0 | 202 |
| 2017 | 0 | — | 0 | 303 |
| 2018 | 1 | — | 0 | 318 |
| 2019 | 0 | — | 0 | 372 |
| 2020 | 0 | — | 0 | 70 |
| 2021 | 0 | — | 0 | 16 |
| 2022 | 1 | — | 0 | 60 |
| 2023 | 0 | — | 0 | 47 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Speedband™ Superview Super7 is indicated for use in endoscopic ligation of esophageal varices and anorectal hemorrhoids.
The Injection Speedband™ Superview Super7 is indicated for use in endoscopic treatment of esophageal varices utilizing combination ligation/injection therapy. The Injection Speedband™ Superview Super7 is also indicated for band ligation treatment of anorectal hemorrhoids.
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/K020824 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020824: Speedband Superview Super 7, Injection Speedband Superview Super 7, Models 4205 and 4238.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020824
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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