510(k) · Cleared
ClearedAblation Confirmation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuwave Medical, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Jun 29, 2016 as substantially equivalent to K150313 (Neuwave Medical, Inc., 2015) after a 51-day review. Its family tree reaches back 4 generations to 2000. 3 later devices descend from it.
- Decided
- Jun 29, 2016
- Review
- 51 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001284 (2000). 6 ancestors in all, the oldest K974513 (1998). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK001284 Stealthstation System Goldeneye Micro-Magnetic Tracking SystemMedtronic Surgical Navigation Technologies · 2000 · Recalled
- 3 generations backK060903 IG4 Image Guided SystemVeran Medical Technologies, Inc. · 2006
- 2 generations backK132108 MAXIOPerfint Healthcare Pvt, Ltd. · 2014
- 1 generation backK150313 Ablation ConfirmationNeuwave Medical, Inc. · 2015
- This deviceK161285 Ablation ConfirmationNeuwave Medical, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK171022 Ablation ConfirmationNeuwave Medical, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK192427 Ablation ConfirmationNeuwave Medical, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK232227 Ablate-IQNeuwave Medical, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001284 | Stealthstation System Goldeneye Micro-Magnetic Tracking System | Medtronic Surgical Navigation Technologies | 2000 | 28 |
| −3 | K060903 | IG4 Image Guided System | Veran Medical Technologies, Inc. | 2006 | — |
| −2 | K132108 | MAXIO | Perfint Healthcare Pvt, Ltd. | 2014 | — |
| −1 | K150313 | Ablation Confirmation | Neuwave Medical, Inc. | 2015 | — |
| 0 (this device) | K161285 | Ablation Confirmation | Neuwave Medical, Inc. | 2016 | — |
| +1 | K171022 | Ablation Confirmation | Neuwave Medical, Inc. | 2017 | — |
| +2 | K192427 | Ablation Confirmation | Neuwave Medical, Inc. | 2019 | — |
| +3 | K232227 | Ablate-IQ | Neuwave Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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 |
|---|---|---|---|
| * | K150313 | Ablation ConfirmationSummary page 4…ng currently marketed device: Ablation Confirmation Software – Class II – 21CFR892.1750 which has been the subject of a cleared 510(k) with the FDA log number K150313. Indications For Use Ablation Confirmation™ (AC), is a Computed Tomography (CT) image processing software package available as a… | 2015 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171022 | Ablation Confirmation | 2017 | 2 |
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 16 years and passes through 4 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K171022 (Neuwave Medical, Inc., 2017) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K150313.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
Ablation Confirmation™ (AC), is a Computed Tomography (CT) image processing software package available as an optional feature for use with the Certus® 140 2.45 GHz Ablation System. AC is controlled by the user via an independent user interface on a second monitor separate from the Certus 140 user interface. AC imports images from CT scanners and facility PACS systems for display and processing during ablation procedures. AC assists physicians in identifying ablation targets, assessing proper ablation probe placement and confirming ablation zones. The software is not intended for diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161285 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161285: Ablation Confirmation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161285
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