510(k) · Cleared
ClearedSonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
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 Dec 21, 2023 as substantially equivalent to K222304 (Gynesonics, Inc., 2022) after a 16-day review. Its family tree reaches back 10 generations to 1994. 2 later devices descend from it.
- Decided
- Dec 21, 2023
- Review
- 16 days
- Class
- Class II
- Product code
- KNF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K934041 (1994). 41 ancestors in all, the oldest K850478 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK934041 Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co. · 1994
- 6 generations between
- 3 generations backK193516 Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc. · 2020
- 2 generations backK211535 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2021
- 1 generation backK222304 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2022
- This deviceK233848 Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK240503 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK250705 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2025
Show all 10 generations
- Root · 10 generations backK934041 Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co. · 1994
- 9 generations backK964309 Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co. · 1997
- 8 generations backK982800 Ecton Lynx Ultrasound SystemEcton, Inc. · 1998
- 7 generations backK021497 Cypress Ultrasound SystemAcuson Corp. · 2002 · Recalled
- 6 generations backK080234 Terason Echo T/3000 Ultrasound System with Stress EchoTeratech Corp. · 2008
- 5 generations backK110020 Terason T3200 Ultrasound SystemTeratech Corp. · 2011
- 4 generations backK173703 Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc. · 2018
- 3 generations backK193516 Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc. · 2020
- 2 generations backK211535 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2021
- 1 generation backK222304 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2022
- This deviceK233848 Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K934041 | Hewlett Packard Conos Ultrasound Imaging System Modification | Hewlett-Packard Co. | 1994 | — |
| −9 | K964309 | Sonos 2000, Sonos 2500 (M2406 a) | Hewlett-Packard Co. | 1997 | — |
| −8 | K982800 | Ecton Lynx Ultrasound System | Ecton, Inc. | 1998 | — |
| −7 | K021497 | Cypress Ultrasound System | Acuson Corp. | 2002 | 2 |
| −6 | K080234 | Terason Echo T/3000 Ultrasound System with Stress Echo | Teratech Corp. | 2008 | — |
| −5 | K110020 | Terason T3200 Ultrasound System | Teratech Corp. | 2011 | — |
| −4 | K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System | Gynesonics, Inc. | 2018 | — |
| −3 | K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 | Gynesonics, Inc. | 2020 | — |
| −2 | K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2021 | — |
| −1 | K222304 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2022 | — |
| 0 (this device) | 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 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K222304 | Sonata Transcervical Fibroid Ablation System 2.2Summary page 5…Predicate Trade Name (Primary Predicate is 510(k) Product Code listed first) K222304 Sonata® Transcervical Fibroid Ablation System 2.2 KNF Device Description: The Sonata System 2.2 provides radio… | 2022 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240503 | Sonata Transcervical Fibroid Ablation System 2.2 | 2024 | 1 |
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 29 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 41 ancestors have a recall of any class.
- Of its descendants, K240503 (Gynesonics, Inc., 2024) has gone furthest, with 1 descendant of its own.
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. 2023, 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 as stated in the FDA summary.
https://510kreport.com/device/K233848 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233848: Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233848
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