510(k) Report

510(k) · Cleared

Cleared

Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating System

K042096510(k) TraditionalCleared Jan 26, 2006540-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Misonix, Inc. · NTB System, Ablation, Ultrasound And Accessories

Cleared on Jan 26, 2006 as substantially equivalent to K983214 (Rita Medical Systems, 2000) and 4 other predicates after a 540-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.

Decided
Jan 26, 2006
Review
540 days
Class
Class II
Product code
NTB
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K901540 (1991). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor2008: 1 descendant cleared2016: 1 descendant clearedK901540 · Model RFG-3C Radiofrequency Lesion Generator · Radionics, Inc. · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K901540 · Model RFG-3C Radiofrequency Lesion Generator · Radionics, Inc. · 19910
  1. Root · 1 generation backK901540 Model RFG-3C Radiofrequency Lesion GeneratorRadionics, Inc. · 1991
  2. This deviceK042096 Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating SystemMisonix, Inc. · 2006
  3. Descendant · cites it directly · 1 of its ownK070779 Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc. · 2008
  4. Descendant · 2 generations on · 0 of its ownK150019 TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc. · 2016

Most influential descendants

Showing 2 of 2 · See all
  • K070779Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc. · 2008 · cites it directly1descendant
  • K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K901540Model RFG-3C Radiofrequency Lesion GeneratorRadionics, Inc.1991—
0 (this device)K042096Misonix Inc. Sonatherm 600 Ultrasonic Lesion Generating SystemMisonix, Inc.2006—
+1K070779Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc.2008—
+2K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200110
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201610
FIG. 1 — Lineage of K042096, 1991–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K983214Rita RF Generator and Accessories, Model 500 Series
Summary page 1
…ssilfication Name: Instrument. UIltrasonic Surgical Predicate Dev ice Inftormation Rita Medical Systems Model 500 (K983214) and 1500 RF (K993944) (Generator Systems and Accessories…
Rita Medical Systems2000—
*K993944Rita Model 1500 Electrosurgical Generator, Power Cord,Footswitch,Main Cable, Dispersive…
Summary page 1
…Instrument. UIltrasonic Surgical Predicate Dev ice Inftormation Rita Medical Systems Model 500 (K983214) and 1500 RF (K993944) (Generator Systems and Accessories AFx hnC. Microwave…
Rita Medical Systems1999—
*K003978Afx Microwave Generator, Flex Ablation Wand, Lynx Ablation Wand, Model Series 1000, P/N…
Summary page 1
…K993944) (Generator Systems and Accessories AFx hnC. Microwave Surgical System and Accessories (K003978) IkdoC are ('Crocarc Stirgical S stem (K01 1074). Radio…
Afx, Inc.2001—
*K011074Cryocare Surgical System
Summary page 1
…AFx hnC. Microwave Surgical System and Accessories (K003978) IkdoC are ('Crocarc Stirgical S stem (K01 1074). Radionics RIl G-3C RF Lesion Generator (K901540) 4. Dex ice I)escription…
Endocare, Inc.20022
*K901540Model RFG-3C Radiofrequency Lesion Generator
Summary page 1
…03978) IkdoC are ('Crocarc Stirgical S stem (K01 1074). Radionics RIl G-3C RF Lesion Generator (K901540) 4. Dex ice I)escription Sonuthemi 600 l ltasonic Lesion (ienerating System is comprised oF'a…
Radionics, Inc.1991—

Also cleared against K983214: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070779Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc.20081

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?

  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K070779 (Misonix, Inc., 2008) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K983214.

How does its category compare?

All NTB devices

NTB System, Ablation, Ultrasound And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NTB

1in 2016

2008: 12016: 1
2007high 1 (2008) · low 0 (2007)2026

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

2007: 22008: 52009: 192010: 52012: 2
2007high 19 (2009) · low 0 (2011)2025

MAUDE reports naming product code NTB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20081—05
20090—019
20100—05
20110—00
20120—02
20130—00
20140—00
20150—00
20161—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Sonatherm is indicated For the laparoseopic or intraopenrtive ablation of soil tissue

from the ultrasound tbcal zone back to the surtice ofethe targeted treatment area in

General SUrgery.

Indications for use as stated in the FDA summary.

Also cleared against K983214

1 other device cites the same predicate.

  • K021329Rita SystemRita Medical Systems · 2002

More from Misonix, Inc.

17 FDA decisions under this applicant name. See the company

  • K221235neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2022
  • K212060neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2021
  • K190160neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2019
  • K123980Sonicone Plus Ultrasound Wound Care System and AccessoriesMisonix, Inc. · 2013
  • K112782Misonix Sonicone (R) Ultrasonic Wound Care System and AccessoriesMisonix, Inc. · 2011

Recent decisions in NTB

The NTB category page

  • K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc. · 2016
  • K070779Sonatherm 600I Ultrasonic Lesion Generating SystemMisonix, Inc. · 2008
  • K060346Ultrazonix Spine Minimal-Invasive Disc SystemUltrazonix Dnt AB · 2006
  • K040641Ultracinch Ablation Device, Ultracinch Accessory Pack, Models UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14…Epicor Medical, Inc. · 2004
  • K022894Epicor Medical Ablation SystemEpicor Medical, Inc. · 2004

https://510kreport.com/device/K042096 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042096: Misonix Inc. Sonatherm 600 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/K042096

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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