510(k) · Cleared
ClearedAveCure BT Microwave Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medwaves, Inc. · NEY System, Ablation, Microwave And Accessories
Cleared on Nov 25, 2020 as substantially equivalent to K161949 (Baylis Medical Company, Inc., 2017) after a 448-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Nov 25, 2020
- Review
- 448 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K943450 (1995). 47 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 6 generations between
- 3 generations backK142480 OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc. · 2015
- 2 generations backK152057 OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2015
- 1 generation backK161949 OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2017
- This deviceK192406 AveCure BT Microwave Ablation SystemMedwaves, Inc. · 2020
Show all 10 generations
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 5 generations backK992581 Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord…Arthrocare Corp. · 1999
- 4 generations backK091310 Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model…Dfine, Inc. · 2010
- 3 generations backK142480 OsteoCool V-2 RF Ablation SystemBaylis Medical Company, Inc. · 2015
- 2 generations backK152057 OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2015
- 1 generation backK161949 OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc. · 2017
- This deviceK192406 AveCure BT Microwave Ablation SystemMedwaves, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −9 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −5 | K992581 | Arthrocare Controller, Arthrocare Cable, Footswitch, Powercord, Spine Wands… | Arthrocare Corp. | 1999 | — |
| −4 | K091310 | Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682 | Dfine, Inc. | 2010 | — |
| −3 | K142480 | OsteoCool V-2 RF Ablation System | Baylis Medical Company, Inc. | 2015 | — |
| −2 | K152057 | OsteoCool V-3 RF Ablation System | Baylis Medical Company, Inc. | 2015 | — |
| −1 | K161949 | OsteoCool V-3 RF Ablation System | Baylis Medical Company, Inc. | 2017 | — |
| 0 (this device) | K192406 | AveCure BT Microwave Ablation System | Medwaves, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 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 NEY? 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 NEY device
- #1 K253771 Disposable Microwave Ablation Antenna…score 14.5 · 13 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 |
|---|---|---|---|
| * | K161949 | OsteoCool V-3 RF Ablation SystemSummary page 4…rator-controller is the durable component of the system and is supplied non-sterile. Predicate Devices: Baylis Medical OsteoCool® V-3 RF Ablation System: K161949: Class II, 21 CFR 878.4400, GEI Reference Devices: MedWaves AveCure Microwave Ablation System K143203: Cl… | 2017 |
| † | K143203 | AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe… | 2015 |
| † | K070356 | Medwaves Microwave Coagulation/Ablation System | 2007 |
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 25 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 47 ancestors have a recall of any class.
- 1 other device also cites its predicate K161949.
How does its category compare?
All NEY devicesNEY System, Ablation, Microwave And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NEY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NEY
94in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NEY
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NEY
112in 2025
MAUDE reports naming product code NEY, 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 | 2 | — | 0 | 18 |
| 2008 | 3 | 145 | 0 | 15 |
| 2009 | 4 | 169 | 0 | 7 |
| 2010 | 3 | 219 | 0 | 28 |
| 2011 | 0 | — | 0 | 26 |
| 2012 | 3 | 81 | 0 | 9 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 1 | — | 0 | 27 |
| 2015 | 2 | — | 0 | 92 |
| 2016 | 3 | 30 | 0 | 176 |
| 2017 | 3 | 121 | 12 | 225 |
| 2018 | 3 | 90 | 3 | 102 |
| 2019 | 2 | — | 0 | 123 |
| 2020 | 7 | 178 | 0 | 128 |
| 2021 | 4 | 379 | 1 | 217 |
| 2022 | 1 | — | 1 | 142 |
| 2023 | 9 | 155 | 0 | 106 |
| 2024 | 7 | 94 | 0 | 141 |
| 2025 | 1 | — | 0 | 112 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The AveCure BT Microwave Ablation System is intended for:
» Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
» Coagulation and ablation of tissue in bone during surgical procedures, including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.
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/K192406 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192406: AveCure BT Microwave Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192406
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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