510(k) · Cleared
ClearedFlex 10 Mis Ablation Probe, Model FLX10MI-05
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guidant Corp. · NEY System, Ablation, Microwave And Accessories
Cleared on Jul 27, 2006 as substantially equivalent to K013946 (Afx, Inc., 2002) and 1 other predicate after a 24-day review. Its family tree reaches back 5 generations to 1981.
- Decided
- Jul 27, 2006
- Review
- 24 days
- Class
- Class II
- Product code
- NEY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K811390 (1981). 11 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 backK041340 Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery · 2004
- This deviceK061865 Flex 10 Mis Ablation Probe, Model FLX10MI-05Guidant Corp. · 2006
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 | K041340 | Guidant Microwave Ablation System | Guidant Corporation, Cardiac Surgery | 2004 | — |
| 0 (this device) | K061865 | Flex 10 Mis Ablation Probe, Model FLX10MI-05 | Guidant Corp. | 2006 | — |
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 |
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? (2)
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 |
|---|---|---|---|
| * | K013946 | Flex 10 Accessory for the Afx Microwave Ablation SystemSummary page 1…are substantially equivalent to the equivalence predicate device: FLEX 10® Ablation Probe for the Guidant Microwave Ablation System (K013946, February 27, 2002 and K041340, July 28, 2004) Device The FLEX 10® MIS Ablation Probe is designed for use in con… | 2002 |
| * | K041340 | Guidant Microwave Ablation SystemSummary page 1…o the equivalence predicate device: FLEX 10® Ablation Probe for the Guidant Microwave Ablation System (K013946, February 27, 2002 and K041340, July 28, 2004) Device The FLEX 10® MIS Ablation Probe is designed for use in conjunction with the description… | 2004 |
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 5 companies; a new generation was cleared every 2.4 years on median.
- None of the 11 ancestors has a recall.
- 8 other devices also cite its predicate K013946.
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 FLEX 10® MIS Ablation Probe 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 as stated in the FDA summary.
https://510kreport.com/device/K061865 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061865: Flex 10 Mis Ablation Probe, Model FLX10MI-05.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061865
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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