510(k) · Cleared
ClearedSpeedboat Flush SB1 Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Creo Medical, Ltd. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Oct 31, 2023 after a 267-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 3 later devices descend from it.
- Decided
- Oct 31, 2023
- Review
- 267 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 1
3 later devices descend from it, 3 citing it directly.
- This deviceK230328 Speedboat Flush SB1 InstrumentCreo Medical, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK242774 SpydrBlade Flex Instrument (PRD-RG1-001)Creo Medical, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK242983 CROMA Electrosurgical Generator (PRD-EMR-050)Creo Medical, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK242061 Reusable Interface Cable 1.5 m (PRD-IFC-002)Creo Medical, Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See all- K242774SpydrBlade Flex Instrument (PRD-RG1-001)Creo Medical, Ltd. · 2025 · cites it directly0descendants
- K242983CROMA Electrosurgical Generator (PRD-EMR-050)Creo Medical, Ltd. · 2025 · cites it directly0descendants
- K242061Reusable Interface Cable 1.5 m (PRD-IFC-002)Creo Medical, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K230328 | Speedboat Flush SB1 Instrument | Creo Medical, Ltd. | 2023 | — |
| +1 | K242774 | SpydrBlade Flex Instrument (PRD-RG1-001) | Creo Medical, Ltd. | 2025 | — |
| +1 | K242983 | CROMA Electrosurgical Generator (PRD-EMR-050) | Creo Medical, Ltd. | 2025 | — |
| +1 | K242061 | Reusable Interface Cable 1.5 m (PRD-IFC-002) | Creo Medical, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 2 | 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 KNS? 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 KNS device
- #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K190317 | FDA’s K190317 is Zavation Spinal System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2019 |
What descends from it? (3)
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, K242774 (Creo Medical, Ltd., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KNS devicesKNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · KNS
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 2025
MAUDE reports naming product code KNS, 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 | — | 3 | 164 |
| 2008 | 3 | 61 | 5 | 587 |
| 2009 | 3 | 212 | 2 | 1,027 |
| 2010 | 4 | 168 | 0 | 908 |
| 2011 | 1 | — | 2 | 860 |
| 2012 | 2 | — | 0 | 848 |
| 2013 | 2 | — | 0 | 449 |
| 2014 | 1 | — | 0 | 405 |
| 2015 | 3 | 252 | 0 | 406 |
| 2016 | 3 | 30 | 6 | 457 |
| 2017 | 3 | 48 | 1 | 446 |
| 2018 | 5 | 62 | 0 | 563 |
| 2019 | 7 | 66 | 0 | 668 |
| 2020 | 4 | 212 | 0 | 906 |
| 2021 | 4 | 139 | 41 | 814 |
| 2022 | 3 | 182 | 0 | 913 |
| 2023 | 9 | 83 | 0 | 976 |
| 2024 | 3 | 198 | 14 | 1,533 |
| 2025 | 11 | 171 | 0 | 1,504 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
Intended for use in the cutting of soft tissue using radiofrequency current, the coagulation (hemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract.
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/K230328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230328: Speedboat Flush SB1 Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230328
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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