510(k) · Cleared
ClearedCreo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory
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 Aug 17, 2017 as substantially equivalent to K092309 (Olympus Medical Systems Corporation, 2009) and 2 other predicates after a 48-day review. Its family tree reaches back 5 generations to 1985. 1 later device descends from it.
- Decided
- Aug 17, 2017
- Review
- 48 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K854238 (1985). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK854238 Needle W/Stylet for ImplantationMicrovasive · 1985
- 4 generations backK942301 Microvasive Injection Gold ProbeBoston Scientific Corp · 1994
- 3 generations backK961349 Injection Gold ProbeBoston Scientific Corp · 1996
- 2 generations backK110887 Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation · 2011
- 1 generation backK133933 Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation · 2014
- This deviceK171983 Creo Medical Electrosurgical System including Speedboat RS2 Surgical…Creo Medical, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK192905 Creo Electrosurgical System with HS1 Hemostasis AccessoryCreo Medical, Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K192905Creo Electrosurgical System with HS1 Hemostasis AccessoryCreo Medical, Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K854238 | Needle W/Stylet for Implantation | Microvasive | 1985 | — |
| −4 | K942301 | Microvasive Injection Gold Probe | Boston Scientific Corp | 1994 | — |
| −3 | K961349 | Injection Gold Probe | Boston Scientific Corp | 1996 | — |
| −2 | K110887 | Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific Corporation | 2011 | — |
| −1 | K133933 | Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific Corporation | 2014 | — |
| 0 (this device) | K171983 | Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory | Creo Medical, Ltd. | 2017 | — |
| +1 | K192905 | Creo Electrosurgical System with HS1 Hemostasis Accessory | Creo Medical, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 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? (3)
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 |
|---|---|---|---|
| * | K092309 | Single Use Electrosurgical Knife Series, Model KD-610L, KD-611L, KD-620LR, KD-630L…Summary page 4…KNS Classification: Class II 3. PREDICATE DEVICES Olympus Hook Knife, single-use electrosurgical knife K092309 Boston Scientific Injection Gold Probe, bipolar electrohemostasis catheter K133933 ERBE VIO 300 D electrosurgical… | 2009 |
| * | K133933 | Injection Gold Probe Bipolar Electrohemostasis CatheterSummary page 4…, single-use electrosurgical knife K092309 Boston Scientific Injection Gold Probe, bipolar electrohemostasis catheter K133933 ERBE VIO 300 D electrosurgical generator K083452 4. SYSTEM DESCRIPTION The… | 2014 |
| * | K083452 | Erbe Model Vio 300 D with AccessoriesSummary page 4…Injection Gold Probe, bipolar electrohemostasis catheter K133933 ERBE VIO 300 D electrosurgical generator K083452 4. SYSTEM DESCRIPTION The Creo Medical Electrosurgical System comprises: • Speedboat RS2 surgical instrument (7-RS2-001)… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192905 | Creo Electrosurgical System with HS1 Hemostasis Accessory | 2020 | 0 |
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 32 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K192905 (Creo Medical, Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K092309.
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. 2017, 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 as stated in the FDA summary.
https://510kreport.com/device/K171983 · printed Nov 3, 2026
Cite this page
510(k) Report. “K171983: Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K171983
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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