510(k) · Cleared
ClearedCanady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Us Medical Innovations, LLC · OAB Low Energy Direct Current Thermal Ablation System
Cleared on May 3, 2024 as substantially equivalent to K192124 (Us Medical Innovations, LLC, 2019) after a 92-day review. Its family tree reaches back 6 generations to 1989.
- Decided
- May 3, 2024
- Review
- 92 days
- Class
- Class II
- Product code
- OAB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K894762 (1989). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
- 5 generations backK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
- 4 generations backK013348 Modification to: Erbe Apc Connector Hose and Probes, Models…Erbe USA, Inc. · 2001
- 3 generations backK052035 Canady Plasma ProbesCanady Technology, LLC · 2005
- 2 generations backK100669 Canady Plasma Electrosurgical Unit Series with Accessory Probes and…Us Medical Innovations, LLC · 2011
- 1 generation backK192124 Canady Plasma SMART XL-1000 Electrosurgical Generator with AccessoriesUs Medical Innovations, LLC · 2019
- This deviceK240297 Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)Us Medical Innovations, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894762 | B100 Disposable Handpiece | Beacon Laboratories, Inc. | 1989 | — |
| −5 | K963189 | Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator… | Erbe USA, Inc. | 1996 | — |
| −4 | K013348 | Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158… | Erbe USA, Inc. | 2001 | — |
| −3 | K052035 | Canady Plasma Probes | Canady Technology, LLC | 2005 | — |
| −2 | K100669 | Canady Plasma Electrosurgical Unit Series with Accessory Probes and Blades | Us Medical Innovations, LLC | 2011 | — |
| −1 | K192124 | Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories | Us Medical Innovations, LLC | 2019 | — |
| 0 (this device) | K240297 | Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) | Us Medical Innovations, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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 OAB? 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 OAB device
- #1 K253826 Aliya® EX System; Aliya® EX Generator; Aliya®…score 15.2 · 14 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192124 | Canady Plasma SMART XL-1000 Electrosurgical Generator with AccessoriesSummary page 5…Legally Marketed Predicate Device: Trade Name: Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories 510(k) Number: K192124 Manufacturer: US Medical Innovations LLC Regulation Number: 21 CFR 878.4400 Regulation Name:… | 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 35 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 15 ancestors has a recall.
How does its category compare?
All OAB devicesOAB Low Energy Direct Current Thermal Ablation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OAB
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OAB
129in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAB
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAB
10in 2025
MAUDE reports naming product code OAB, 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 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 0 | — | 1 | 82 |
| 2013 | 0 | — | 0 | 17 |
| 2014 | 0 | — | 0 | 18 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 0 | — | 1 | 16 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 1 | — | 0 | 10 |
| 2024 | 4 | 129 | 0 | 14 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 3 | 179 | 0 | — |
What is it indicated for?
The Canady Helios Cold Plasma™ XL-1000CP™ Ablation System is indicated for the gas enhanced ablation of soft tissue using helium-based plasma.
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/K240297 · printed Nov 3, 2026
Cite this page
510(k) Report. “K240297: Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K240297
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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