510(k) · Cleared
ClearedSonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
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 May 4, 2020 as substantially equivalent to K173703 (Gynesonics, Inc., 2018) after a 137-day review. Its family tree reaches back 7 generations to 1994. 5 later devices descend from it.
- Decided
- May 4, 2020
- Review
- 137 days
- Class
- Class II
- Product code
- KNF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K934041 (1994). 38 ancestors in all, the oldest K850478 (1985). 5 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK934041 Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co. · 1994
- 6 generations backK964309 Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co. · 1997
- 5 generations backK982800 Ecton Lynx Ultrasound SystemEcton, Inc. · 1998
- 4 generations backK021497 Cypress Ultrasound SystemAcuson Corp. · 2002 · Recalled
- 3 generations backK080234 Terason Echo T/3000 Ultrasound System with Stress EchoTeratech Corp. · 2008
- 2 generations backK110020 Terason T3200 Ultrasound SystemTeratech Corp. · 2011
- 1 generation backK173703 Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc. · 2018
- This deviceK193516 Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc. · 2020
- Descendant · cites it directly · 4 of its ownK211535 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2021
- Descendant · 2 generations on · 3 of its ownK222304 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2022
- Descendant · 3 generations on · 2 of its ownK233848 Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc. · 2023
- Descendant · 4 generations on · 1 of its ownK240503 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2024
- Descendant · 5 generations on · 0 of its ownK250705 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2025
Most influential descendants
Showing 5 of 5 · See all- K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2021 · cites it directly4descendants
- K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2022 · 2 generations on3descendants
- K233848Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)Gynesonics, Inc. · 2023 · 3 generations on2descendants
- K240503Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2024 · 4 generations on1descendant
- K250705Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K934041 | Hewlett Packard Conos Ultrasound Imaging System Modification | Hewlett-Packard Co. | 1994 | — |
| −6 | K964309 | Sonos 2000, Sonos 2500 (M2406 a) | Hewlett-Packard Co. | 1997 | — |
| −5 | K982800 | Ecton Lynx Ultrasound System | Ecton, Inc. | 1998 | — |
| −4 | K021497 | Cypress Ultrasound System | Acuson Corp. | 2002 | 2 |
| −3 | K080234 | Terason Echo T/3000 Ultrasound System with Stress Echo | Teratech Corp. | 2008 | — |
| −2 | K110020 | Terason T3200 Ultrasound System | Teratech Corp. | 2011 | — |
| −1 | K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System | Gynesonics, Inc. | 2018 | — |
| 0 (this device) | K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 | Gynesonics, Inc. | 2020 | — |
| +1 | K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2021 | — |
| +2 | K222304 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2022 | — |
| +3 | K233848 | Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) | Gynesonics, Inc. | 2023 | — |
| +4 | K240503 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2024 | — |
| +5 | 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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation SystemSummary page 5…been subject to design-related recalls. Table 1 Table of Predicate and Reference Device 510(k) Product 510(k) Holder Clearance Date K173703 Sonata® System Gynesonics August 15, 2018 Terason™ uSMART3200T K150533… | 2018 |
| † | K150533 | Terason uSmart3200T Ultrasound System | 2015 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | 2021 | 4 |
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 26 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 38 ancestors have a recall of any class.
- Of its descendants, K211535 (Gynesonics, Inc., 2021) has gone furthest, with 4 descendants 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. 2020, 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® Sonography-Guided Transcervical Fibroid Ablation System 2.1 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/K193516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193516: Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193516
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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