510(k) · Cleared
ClearedCanady Plasma SMART XL-1000 Electrosurgical Generator with Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Us Medical Innovations, LLC · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 21, 2019 as substantially equivalent to K100669 (Us Medical Innovations, LLC, 2011) after a 107-day review. Its family tree reaches back 5 generations to 1989. 1 later device descends from it.
- Decided
- Nov 21, 2019
- Review
- 107 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K894762 (1989). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
- 4 generations backK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
- 3 generations backK013348 Modification to: Erbe Apc Connector Hose and Probes, Models…Erbe USA, Inc. · 2001
- 2 generations backK052035 Canady Plasma ProbesCanady Technology, LLC · 2005
- 1 generation backK100669 Canady Plasma Electrosurgical Unit Series with Accessory Probes and…Us Medical Innovations, LLC · 2011
- This deviceK192124 Canady Plasma SMART XL-1000 Electrosurgical Generator with AccessoriesUs Medical Innovations, LLC · 2019
- Descendant · cites it directly · 0 of its ownK240297 Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)Us Medical Innovations, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K240297Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)Us Medical Innovations, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894762 | B100 Disposable Handpiece | Beacon Laboratories, Inc. | 1989 | — |
| −4 | K963189 | Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator… | Erbe USA, Inc. | 1996 | — |
| −3 | K013348 | Modification to: Erbe Apc Connector Hose and Probes, Models 20132-158… | Erbe USA, Inc. | 2001 | — |
| −2 | K052035 | Canady Plasma Probes | Canady Technology, LLC | 2005 | — |
| −1 | K100669 | Canady Plasma Electrosurgical Unit Series with Accessory Probes and Blades | Us Medical Innovations, LLC | 2011 | — |
| 0 (this device) | K192124 | Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories | Us Medical Innovations, LLC | 2019 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K100669 | Canady Plasma Electrosurgical Unit Series with Accessory Probes and BladesSummary page 4…Class: 2 Classification Panel: General and Plastic Surgery 5. Legally Marketed Predicate Device Canady Plasma® Electrosurgical Unit SS Series with Accessories (K100669) 6. Indication for Use Statement Page 1 of 5… | 2011 |
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 |
|---|---|---|---|
| K240297 | Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) | 2024 | 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 30 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K240297 (Us Medical Innovations, LLC, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories is intended to provide gas-enhanced coagulation during general surgery procedures. The Canady Plasma® SMART XL-1000™ Electrosurgical Generator with Accessories is designed for gas enhanced coagulation when used only with the Canady Plasma Electrosurgery Unit and compatible monopolar and/or bipolar handpieces.
The Canady Electrosurgery Unit Generators are intended to cut and/or coagulate tissue when used with compatible monopolar and/or bipolar RF handpieces. The Canady Electrosurgery Unit Generators are capable of monopolar argon gas enhanced coagulation when used with Canady Plasma Coagulator and probes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192124: Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192124
Report an extraction error
Are you the manufacturer?
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