510(k) · Cleared
ClearedSonata Transcervical Fibroid Ablation System 2.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gynesonics, Inc. · KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Cleared on Apr 2, 2025 as substantially equivalent to K240503 (Gynesonics, Inc., 2024) after a 23-day review. Its family tree reaches back 12 generations to 1994.
- Decided
- Apr 2, 2025
- Review
- 23 days
- Class
- Class II
- Product code
- KNF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K934041 (1994). 43 ancestors in all, the oldest K850478 (1985). No later device cites it as a predicate yet.
- Root · 12 generations backK934041 Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co. · 1994
- 8 generations between
- 3 generations backK222304 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2022
- 2 generations backK233848 Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc. · 2023
- 1 generation backK240503 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2024
- This deviceK250705 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2025
Show all 12 generations
- Root · 12 generations backK934041 Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co. · 1994
- 11 generations backK964309 Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co. · 1997
- 10 generations backK982800 Ecton Lynx Ultrasound SystemEcton, Inc. · 1998
- 9 generations backK021497 Cypress Ultrasound SystemAcuson Corp. · 2002 · Recalled
- 8 generations backK080234 Terason Echo T/3000 Ultrasound System with Stress EchoTeratech Corp. · 2008
- 7 generations backK110020 Terason T3200 Ultrasound SystemTeratech Corp. · 2011
- 6 generations backK173703 Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc. · 2018
- 5 generations backK193516 Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc. · 2020
- 4 generations backK211535 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2021
- 3 generations backK222304 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2022
- 2 generations backK233848 Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc. · 2023
- 1 generation backK240503 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2024
- This deviceK250705 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K934041 | Hewlett Packard Conos Ultrasound Imaging System Modification | Hewlett-Packard Co. | 1994 | — |
| −11 | K964309 | Sonos 2000, Sonos 2500 (M2406 a) | Hewlett-Packard Co. | 1997 | — |
| −10 | K982800 | Ecton Lynx Ultrasound System | Ecton, Inc. | 1998 | — |
| −9 | K021497 | Cypress Ultrasound System | Acuson Corp. | 2002 | 2 |
| −8 | K080234 | Terason Echo T/3000 Ultrasound System with Stress Echo | Teratech Corp. | 2008 | — |
| −7 | K110020 | Terason T3200 Ultrasound System | Teratech Corp. | 2011 | — |
| −6 | K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System | Gynesonics, Inc. | 2018 | — |
| −5 | K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 | Gynesonics, Inc. | 2020 | — |
| −4 | K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2021 | — |
| −3 | K222304 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2022 | — |
| −2 | K233848 | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) | Gynesonics, Inc. | 2023 | — |
| −1 | K240503 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2024 | — |
| 0 (this device) | K250705 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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 KNF? 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 KNF device
- #1 K240503 Sonata Transcervical Fibroid Ablation System 2.2score 13.7 · 11 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 |
|---|---|---|---|
| * | K240503 | Sonata Transcervical Fibroid Ablation System 2.2Summary page 5…4.4160 Product Code: KNF, ITX, IYO Legally Marketed Predicate Devices 510(k) Predicate Trade Name (Primary Predicate is listed first) Product Code K240503 Sonata Transcervical Fibroid Ablation System 2.2 KNF The predicate device has not been subject to a design-relat… | 2024 |
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 31 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 43 ancestors have a recall of any class.
How does its category compare?
All KNF devicesKNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · KNF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNF
Too few KNF 510(k)s in any year since 2007 to give a median.
Recalls per year · KNF
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNF
93in 2025
MAUDE reports naming product code KNF, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 3 | 1 |
| 2010 | 1 | — | 0 | 14 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 1 | — | 1 | 24 |
| 2014 | 1 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 1 | — | 0 | 13 |
| 2019 | 0 | — | 0 | 18 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 1 | — | 0 | 93 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Sonata® Transcervical Fibroid Ablation System is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding.
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/K250705 · printed Nov 3, 2026
Cite this page
510(k) Report. “K250705: Sonata Transcervical Fibroid Ablation System 2.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K250705
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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