510(k) · Cleared
ClearedMicrosurgeon Microwave Tissue Ablation Device, Model Mtad-200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microsurgeon, Inc. · NEY System, Ablation, Microwave And Accessories
Cleared on Feb 12, 2009 as substantially equivalent to K070023 (Microsurgeon, Inc., 2007) after a 161-day review. Its family tree reaches back 5 generations to 1981.
- Decided
- Feb 12, 2009
- Review
- 161 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K811390 (1981). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK811390 CCS100 Cryosurgical SystemFrigitronics of Connecticut, Inc. · 1981
- 4 generations backK972662 Cryogen Cryosurgical SystemCryogen, Inc. · 1997
- 3 generations backK974320 Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998
- 2 generations backK013946 Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002
- 1 generation backK070023 Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Microsurgeon, Inc. · 2007
- This deviceK082565 Microsurgeon Microwave Tissue Ablation Device, Model Mtad-200Microsurgeon, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K811390 | CCS100 Cryosurgical System | Frigitronics of Connecticut, Inc. | 1981 | — |
| −4 | K972662 | Cryogen Cryosurgical System | Cryogen, Inc. | 1997 | — |
| −3 | K974320 | Cryogen Cardiac Cryosurgical System | Cryogen, Inc. | 1998 | — |
| −2 | K013946 | Flex 10 Accessory for the Afx Microwave Ablation System | Afx, Inc. | 2002 | — |
| −1 | K070023 | Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100 | Microsurgeon, Inc. | 2007 | — |
| 0 (this device) | K082565 | Microsurgeon Microwave Tissue Ablation Device, Model Mtad-200 | Microsurgeon, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K070023 | Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100Summary page 2…ICE: The legally marketed device/s to which equivalence is being claimed is: MicroSurgeon, Inc 8489 West 3RD Street Suite 1044 Los Angeles, CA 90048 K070023: Microwave Ablation System & Accessories 6. DEVICE DESCRIPTION The MicroSurgeon Microwave Tissue Ablation device model MTAD-2… | 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 28 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 17 ancestors has a recall of any class.
- 1 other device also cites its predicate K070023.
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. 2009, 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 MicroSurgeon Microwave Tissue Ablation Device is intended to
be used for the surgical ablation of soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082565 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082565: Microsurgeon Microwave Tissue Ablation Device, Model Mtad-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082565
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