510(k) · Decided
DecidedCreo Electrosurgical System with HS1 Hemostasis 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 Mar 19, 2020 as substantially equivalent to K133933 (Boston Scientific Corporation, 2014) and 2 other predicates after a 156-day review. Its family tree reaches back 6 generations to 1985.
- Decided
- Mar 19, 2020
- Review
- 156 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K854238 (1985). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK854238 Needle W/Stylet for ImplantationMicrovasive · 1985
- 5 generations backK942301 Microvasive Injection Gold ProbeBoston Scientific Corp · 1994
- 4 generations backK961349 Injection Gold ProbeBoston Scientific Corp · 1996
- 3 generations backK110887 Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation · 2011
- 2 generations backK133933 Injection Gold Probe Bipolar Electrohemostasis CatheterBoston Scientific Corporation · 2014
- 1 generation backK171983 Creo Medical Electrosurgical System including Speedboat RS2 Surgical…Creo Medical, Ltd. · 2017
- This deviceK192905 Creo Electrosurgical System with HS1 Hemostasis AccessoryCreo Medical, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K854238 | Needle W/Stylet for Implantation | Microvasive | 1985 | — |
| −5 | K942301 | Microvasive Injection Gold Probe | Boston Scientific Corp | 1994 | — |
| −4 | K961349 | Injection Gold Probe | Boston Scientific Corp | 1996 | — |
| −3 | K110887 | Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific Corporation | 2011 | — |
| −2 | K133933 | Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific Corporation | 2014 | — |
| −1 | K171983 | Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory | Creo Medical, Ltd. | 2017 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K133933 | Injection Gold Probe Bipolar Electrohemostasis CatheterSummary page 4…Regulation number: 21 CFR 876.4300 Product Code: KNS 3.PREDICATE DEVICES Boston Scientific Injection Gold Probe, bipolar electrohemostasis catheter (K133933) ERBE VIO 300 D electrosurgical generator (K083452) Creo Electrosurgical System including Speedboat RS2 surgical accessory… | 2014 |
| * | K083452 | Erbe Model Vio 300 D with AccessoriesSummary page 4…e: KNS 3.PREDICATE DEVICES Boston Scientific Injection Gold Probe, bipolar electrohemostasis catheter (K133933) ERBE VIO 300 D electrosurgical generator (K083452) Creo Electrosurgical System including Speedboat RS2 surgical accessory (RS2) (K171983) 4.ASSOCIATED FDA DOCUMENT NUMBER Q… | 2008 |
| * | K171983 | Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessorySummary page 4…ectrohemostasis catheter (K133933) ERBE VIO 300 D electrosurgical generator (K083452) Creo Electrosurgical System including Speedboat RS2 surgical accessory (RS2) (K171983) 4.ASSOCIATED FDA DOCUMENT NUMBER Q182299 Traditional 510(k) Premarket Notificat… | 2017 |
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 35 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 2 other devices also cite its predicate K133933.
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. 2020, 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?
The Creo Electrosurgical Generator is intended to provide radiofrequency (RF) electrosurgical energy for cutting and microwave energy (MW) for coagulation (hemostasis, cauterization) of soft tissue, and is for use only with compatible Creo Medical instruments and accessories. The HS1 Hemostasis Accessory is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic…
Read the full statement (113 words)
The Creo Electrosurgical Generator is intended to provide radiofrequency (RF) electrosurgical energy for cutting and microwave energy (MW) for coagulation (hemostasis, cauterization) of soft tissue, and is for use only with compatible Creo Medical instruments and accessories.
The HS1 Hemostasis Accessory is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following:
• Peptic Ulcers
• Dieulafoy Lesions
• Mallory-Weiss Tears
• Bleeding Polyp Stalks
• Arteriovenous Malformations (AVMs)
• Angiomata
The HS1 also has irrigation capability. Any other use is not recommended.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192905: Creo Electrosurgical System with HS1 Hemostasis Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192905
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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