510(k) · Cleared
ClearedGuidant Microwave Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corporation, Cardiac Surgery · NEY System, Ablation, Microwave And Accessories
Cleared on Jul 28, 2004 as substantially equivalent to K003978 (Afx, Inc., 2001) and 3 other predicates after a 69-day review. Its family tree reaches back 4 generations to 1981. 1 of the 279 devices in its family, counting itself, has a Class I recall. 268 later devices descend from it.
- Decided
- Jul 28, 2004
- Review
- 69 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K811390 (1981). 10 ancestors in all. 268 later devices descend from it, 3 citing it directly. 1 of the 279 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK811390 CCS100 Cryosurgical SystemFrigitronics of Connecticut, Inc. · 1981
- 3 generations backK972662 Cryogen Cryosurgical SystemCryogen, Inc. · 1997
- 2 generations backK974320 Cryogen Cardiac Cryosurgical SystemCryogen, Inc. · 1998
- 1 generation backK013946 Flex 10 Accessory for the Afx Microwave Ablation SystemAfx, Inc. · 2002
- This deviceK041340 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
- Descendant · 2 generations on · 228 of its ownK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
Showing 5 of 268 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 268 · See all- 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
- K050802Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005 · 2 generations on228descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K811390 | CCS100 Cryosurgical System | Frigitronics of Connecticut, Inc. | 1981 | — |
| −3 | K972662 | Cryogen Cryosurgical System | Cryogen, Inc. | 1997 | — |
| −2 | K974320 | Cryogen Cardiac Cryosurgical System | Cryogen, Inc. | 1998 | — |
| −1 | K013946 | Flex 10 Accessory for the Afx Microwave Ablation System | Afx, Inc. | 2002 | — |
| 0 (this device) | 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 | — |
| +2 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | 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 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 5 | 0 |
| 2008 | 9 | 0 |
| 2009 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 11 | 0 |
| 2015 | 6 | 0 |
| 2016 | 11 | 0 |
| 2017 | 15 | 0 |
| 2018 | 18 | 0 |
| 2019 | 12 | 0 |
| 2020 | 19 | 0 |
| 2021 | 17 | 0 |
| 2022 | 19 | 0 |
| 2023 | 20 | 1 |
| 2024 | 25 | 0 |
| 2025 | 31 | 0 |
| 2026 | 26 | 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? (4)
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…tion Name: Cryosurgical unit and accessories (21 CFR 878.4350); Identification of Predicate Devices AFx Microwave Ablation System and Accessories K003978 FLEX 10 Accessory for the AFx Microwave Ablation System K013946 CryoGen Cardiac Cryosurgery System… | 2001 |
| * | K013946 | Flex 10 Accessory for the Afx Microwave Ablation SystemSummary page 4…on of Predicate Devices AFx Microwave Ablation System and Accessories K003978 FLEX 10 Accessory for the AFx Microwave Ablation System K013946 CryoGen Cardiac Cryosurgery System K974320 HeartportTM Maze System: Cryoprobe Set… | 2002 |
| * | K974320 | Cryogen Cardiac Cryosurgical SystemSummary page 4…K003978 FLEX 10 Accessory for the AFx Microwave Ablation System K013946 CryoGen Cardiac Cryosurgery System K974320 HeartportTM Maze System: Cryoprobe Set K970496 Indications for Use The Guidant Microwave Ablation… | 1998 |
| * | K970496 | Heartport Maze System: Cryoprobe SetSummary page 4…em K013946 CryoGen Cardiac Cryosurgery System K974320 HeartportTM Maze System: Cryoprobe Set K970496 Indications for Use The Guidant Microwave Ablation System is indicated for the surgical ablation of soft tissue, and striated, c… | 1997 |
What descends from it? (268)
See all 2683 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K043153 (Intuitive Surgical, Inc., 2004) has gone furthest, with 251 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 Guidant Microwave Ablation System is indicated for the surgical ablation of soft tissue, and striated, cardiac, and smooth muscles. The System is a device indicated for use, under direct visualization, in surgical procedures, including minimally invasive cardiac surgery procedures. The probes ablate the target tissue by creating an inflammatory response, or thermal necrosis.
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/K041340 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041340: Guidant Microwave Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041340
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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