510(k) · Cleared
ClearedSonatherm 600I Ultrasonic Lesion Generating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Misonix, Inc. · NTB System, Ablation, Ultrasound And Accessories
Cleared on Jul 9, 2008 as substantially equivalent to K042096 (Misonix, Inc., 2006) and 3 other predicates after a 476-day review. Its family tree reaches back 6 generations to 1993. 1 later device descends from it.
- Decided
- Jul 9, 2008
- Review
- 476 days
- Class
- Class II
- Product code
- NTB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K926514 (1993). 22 ancestors in all, the oldest K850478 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 5 generations backK963023 Ultrasound Gastroscope GF Type UM30POlympus America, Inc. · 1997
- 4 generations backK994373 Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal…Atl Ultrasound, Inc. · 2000
- 3 generations backK030191 Terason Model 2000/Bas Portable Ultrasound SystemTeratech Corp. · 2003
- 2 generations backK032333 Cryocare CS Surgical SystemEndocare, Inc. · 2003
- 1 generation backK050347 Modification to Cryocare CS Surgical SystemEndocare, Inc. · 2005
- This deviceK070779 Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK150019 TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −5 | K963023 | Ultrasound Gastroscope GF Type UM30P | Olympus America, Inc. | 1997 | — |
| −4 | K994373 | Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound… | Atl Ultrasound, Inc. | 2000 | — |
| −3 | K030191 | Terason Model 2000/Bas Portable Ultrasound System | Teratech Corp. | 2003 | — |
| −2 | K032333 | Cryocare CS Surgical System | Endocare, Inc. | 2003 | — |
| −1 | K050347 | Modification to Cryocare CS Surgical System | Endocare, Inc. | 2005 | — |
| 0 (this device) | K070779 | Sonatherm 600I Ultrasonic Lesion Generating System | Misonix, Inc. | 2008 | — |
| +1 | K150019 | TheraVision Ultrasound Ablation System and ACOUSTx Applicators | Acoustic Medsystems, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 NTB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K042096 | Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating SystemSummary page 1…ce and accessories and Number, and 21 CFR 878.4400 Product Code: Product Code: NTB Predicate Devices: Sonatherm 600 Ultrasonic Lesion Generating System, K042096 Endocare CryoCare T M Surgical System with CryoGuideTM K002615… | 2006 |
| * | K002615 | Surgical System with CryoguideSummary page 1…Devices: Sonatherm 600 Ultrasonic Lesion Generating System, K042096 Endocare CryoCare T M Surgical System with CryoGuideTM K002615 Endocare CryoCare CS Surgical System K032333 Endocare CryoCare CS Surgical System K05… | 2000 |
| * | K032333 | Cryocare CS Surgical SystemSummary page 1…096 Endocare CryoCare T M Surgical System with CryoGuideTM K002615 Endocare CryoCare CS Surgical System K032333 Endocare CryoCare CS Surgical System K050347 Device Description: The Sonatherm 600i is a modification of… | 2003 |
| * | K050347 | Modification to Cryocare CS Surgical SystemSummary page 1…h CryoGuideTM K002615 Endocare CryoCare CS Surgical System K032333 Endocare CryoCare CS Surgical System K050347 Device Description: The Sonatherm 600i is a modification of the previously cleared Sonatherm 600 (K 04209… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150019 | TheraVision Ultrasound Ablation System and ACOUSTx Applicators | 2016 | 0 |
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 15 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 4 of the 22 ancestors have a recall of any class.
- Of its descendants, K150019 (Acoustic Medsystems, Inc., 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NTB devicesNTB System, Ablation, Ultrasound And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NTB
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · NTB
Too few NTB 510(k)s in any year since 2007 to give a median.
Recalls per year · NTB
No recall names NTB since 2007.
Adverse event reports per year · NTB
2in 2012
MAUDE reports naming product code NTB, 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 | 0 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 19 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sonatherm is indicated for the laparoscopic or intraoperative ablation of soft tissue from the ultrasound focal zone back to the surface of the targeted ablation area in General Surgery. The Sonatherm is not to be used for non-invasive ablation, i.e. leaving intervening tissue spared, and it is not indicated for the ablation of Prostate tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070779 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070779: Sonatherm 600I Ultrasonic Lesion Generating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070779
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