510(k) · Cleared
ClearedFlex 10 Accessory for the Afx Microwave Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Afx, Inc. · NEY System, Ablation, Microwave And Accessories
Cleared on Feb 27, 2002 as substantially equivalent to K003978 (Afx, Inc., 2001) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1981. 1 of the 350 devices in its family, counting itself, has a Class I recall. 340 later devices descend from it.
- Decided
- Feb 27, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K811390 (1981). 9 ancestors in all. 340 later devices descend from it, 9 citing it directly. 1 of the 350 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK811390 CCS100 Cryosurgical SystemFrigitronics of Connecticut, Inc. · 1981
- 2 generations backK972662 Cryogen Cryosurgical SystemCryogen, Inc. · 1997
- 1 generation backK974320 Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998
- This deviceK013946 Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002
- Descendant · cites it directly · 268 of its ownK041340 Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery · 2004
- Descendant · cites it directly · 251 of its ownK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- Descendant · 2 generations on · 231 of its ownK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 230 of its ownK050369 Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 229 of its ownK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
Showing 5 of 340 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K223095 Senhance Surgical System4 generations on · 2023
Most influential descendants
Showing 5 of 340 · See all- K041340Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery · 2004 · cites it directly268descendants
- K043153Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…Intuitive Surgical, Inc. · 2004 · cites it directly251descendants
- K050005Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…Intuitive Surgical, Inc. · 2005 · 2 generations on231descendants
- K050369Intuitive Surgical DA Vinci Surgical System, Model IS2000Intuitive Surgical, Inc. · 2005 · 2 generations on230descendants
- K050404Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · 2 generations on229descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K811390 | CCS100 Cryosurgical System | Frigitronics of Connecticut, Inc. | 1981 | — |
| −2 | K972662 | Cryogen Cryosurgical System | Cryogen, Inc. | 1997 | — |
| −1 | K974320 | Cryogen Cardiac Cryosurgical System | Cryogen, Inc. | 1998 | — |
| 0 (this device) | K013946 | Flex 10 Accessory for the Afx Microwave Ablation System | Afx, Inc. | 2002 | — |
| +1 | K041340 | Guidant Microwave Ablation System | Guidant Corporation, Cardiac Surgery | 2004 | — |
| +1 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| +2 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| +2 | K050369 | Intuitive Surgical DA Vinci Surgical System, Model IS2000 | Intuitive Surgical, Inc. | 2005 | 51 |
| +2 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 12 | 0 |
| 2009 | 7 | 0 |
| 2010 | 3 | 0 |
| 2011 | 7 | 0 |
| 2012 | 8 | 0 |
| 2013 | 7 | 0 |
| 2014 | 12 | 0 |
| 2015 | 7 | 0 |
| 2016 | 13 | 0 |
| 2017 | 17 | 0 |
| 2018 | 21 | 0 |
| 2019 | 15 | 0 |
| 2020 | 26 | 0 |
| 2021 | 22 | 0 |
| 2022 | 22 | 0 |
| 2023 | 26 | 1 |
| 2024 | 34 | 0 |
| 2025 | 34 | 0 |
| 2026 | 28 | 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.
1 device in this family has a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K003978 | Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N…Summary page 4…ion System Common Name: None Classification Name: Cryosurgical unit and accessories (21 CFR 878.4350); Predicate Devices AFx Microwave Ablation System and Accessories K003978 CryoGen Cardiac Cryosurgery System K974320 Heartport Maze System: Cryoprobe Set K970496 Device Description The FLEX 10 Accessory… | 2001 |
| * | K974320 | Cryogen Cardiac Cryosurgical SystemSummary page 4…n Name: Cryosurgical unit and accessories (21 CFR 878.4350); Predicate Devices AFx Microwave Ablation System and Accessories K003978 CryoGen Cardiac Cryosurgery System K974320 Heartport Maze System: Cryoprobe Set K970496 Device Description The FLEX 10 Accessory is a surgical ablation probe that directs… | 1998 |
| * | K970496 | Heartport Maze System: Cryoprobe SetSummary page 4…CFR 878.4350); Predicate Devices AFx Microwave Ablation System and Accessories K003978 CryoGen Cardiac Cryosurgery System K974320 Heartport Maze System: Cryoprobe Set K970496 Device Description The FLEX 10 Accessory is a surgical ablation probe that directs the microwave energy developed by the AFx Mi… | 1997 |
What descends from it? (340)
See all 3409 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041340 | Guidant Microwave Ablation System | 2004 | 268 |
| K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models IS1200 &… | 2004 | 251 |
| K070023 | Microsurgeon Microwave Tissue Ablation Device, Model Mtad-100 | 2007 | 41 |
| K022894 | Epicor Medical Ablation System | 2004 | 23 |
| K040641 | Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11… | 2004 | 22 |
| K070311 | Cardioblate Gemini Surgical Ablation Device, Models 49260 and 49261 | 2007 | 1 |
| K061489 | Atrilaze MI Surgical Ablation System | 2007 | 1 |
| K061865 | Flex 10 Mis Ablation Probe, Model FLX10MI-05 | 2006 | 0 |
| K041739 | Edwards E360 Surgical Ablation Device | 2004 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K041340 (Guidant Corporation, Cardiac Surgery, 2004) has gone furthest, with 268 descendants of its own.
- 11 other devices also cite its predicate K003978.
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.
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 FLEX 10 Accessory is intended to be used with the AFx Microwave Ablation System for the surgical ablation of soft tissue, in addition to striated, cardiac and smooth muscles. The system is designed to ablate tissue by the induction of thermal necrosis in the targeted tissues.
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/K013946 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013946: Flex 10 Accessory for the Afx 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/K013946
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026