510(k) · Cleared
ClearedApyx One Console
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apyx Medical Corporation · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Oct 11, 2022 as substantially equivalent to K192867 (Bovie Medical Corporation Dba Apyx Medical Corporation, 2019) after a 110-day review. Its family tree reaches back 9 generations to 1989.
- Decided
- Oct 11, 2022
- Review
- 110 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K894762 (1989). 22 ancestors in all, the oldest K871435 (1987). No later device cites it as a predicate yet.
- Root · 9 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
- 5 generations between
- 3 generations backK152570 Bovie J-Plasma Precise 360 HandpieceBovie Medical Corporation · 2015 · Recalled
- 2 generations backK170188 Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High…Bovie Medical Corporation · 2017 · Recalled
- 1 generation backK192867 Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)Bovie Medical Corporation Dba Apyx Medical Corporation · 2019
- This deviceK221830 Apyx One ConsoleApyx Medical Corporation · 2022
Show all 9 generations
- Root · 9 generations backK894762 B100 Disposable HandpieceBeacon Laboratories, Inc. · 1989
- 8 generations backK963189 Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma…Erbe USA, Inc. · 1996
- 7 generations backK030819 Plasmajet SystemPlasma Surgical, Ltd. · 2004
- 6 generations backK090586 Bovie Icon GS Electrosurgical Generator (GS100), Handpiece…Bovie Medical · 2009
- 5 generations backK112233 Bovie J-Plasma Handpiece with Retractable Cutting BladeBovie Medical Corporation · 2012
- 4 generations backK151325 Bovie J-Plasma HandpieceBovie Medical Corporation · 2015 · Recalled
- 3 generations backK152570 Bovie J-Plasma Precise 360 HandpieceBovie Medical Corporation · 2015 · Recalled
- 2 generations backK170188 Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High…Bovie Medical Corporation · 2017 · Recalled
- 1 generation backK192867 Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)Bovie Medical Corporation Dba Apyx Medical Corporation · 2019
- This deviceK221830 Apyx One ConsoleApyx Medical Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894762 | B100 Disposable Handpiece | Beacon Laboratories, Inc. | 1989 | — |
| −8 | K963189 | Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator… | Erbe USA, Inc. | 1996 | — |
| −7 | K030819 | Plasmajet System | Plasma Surgical, Ltd. | 2004 | — |
| −6 | K090586 | Bovie Icon GS Electrosurgical Generator (GS100), Handpiece (GS-OP-R), Reusable… | Bovie Medical | 2009 | — |
| −5 | K112233 | Bovie J-Plasma Handpiece with Retractable Cutting Blade | Bovie Medical Corporation | 2012 | — |
| −4 | K151325 | Bovie J-Plasma Handpiece | Bovie Medical Corporation | 2015 | 1 |
| −3 | K152570 | Bovie J-Plasma Precise 360 Handpiece | Bovie Medical Corporation | 2015 | 5 |
| −2 | K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency… | Bovie Medical Corporation | 2017 | 6 |
| −1 | K192867 | Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) | Bovie Medical Corporation Dba Apyx Medical Corporation | 2019 | — |
| 0 (this device) | K221830 | Apyx One Console | Apyx Medical Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1990 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 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 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 |
|---|---|---|---|
| * | K192867 | Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3)Summary page 4…Predicate Device(s): Predicate Device Apyx Helium Plasma Generator (K192867) 2. Indications for Use The Apyx One Console is indicated for the delivery of radiofrequency energy and/or helium p… | 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 33 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 22 ancestors have a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Apyx One Console is indicated for delivery of radiofrequency energy and/or helium plasma to cut, coagulate and ablate soft tissue during open and laparoscopic surgical procedures. The helium plasma portion of the generator can be used only with dedicated Renuvion/J-Plasma handpieces.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221830 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221830: Apyx One Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221830
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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