510(k) · Cleared
ClearedTerason T3200 Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teratech Corp. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jan 20, 2011 as substantially equivalent to K080234 (Teratech Corp., 2008) after a 17-day review. Its family tree reaches back 5 generations to 1994. 13 later devices descend from it.
- Decided
- Jan 20, 2011
- Review
- 17 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K934041 (1994). 21 ancestors in all, the oldest K891689 (1989). 13 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK934041 Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co. · 1994
- 4 generations backK964309 Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co. · 1997
- 3 generations backK982800 Ecton Lynx Ultrasound SystemEcton, Inc. · 1998
- 2 generations backK021497 Cypress Ultrasound SystemAcuson Corp. · 2002 · Recalled
- 1 generation backK080234 Terason Echo T/3000 Ultrasound System with Stress EchoTeratech Corp. · 2008
- This deviceK110020 Terason T3200 Ultrasound SystemTeratech Corp. · 2011
- Descendant · cites it directly · 6 of its ownK173703 Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc. · 2018
- Descendant · 2 generations on · 5 of its ownK193516 Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc. · 2020
- Descendant · 3 generations on · 4 of its ownK211535 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK131209 Terason USMART3200T Ultrasound SystemTeratech Corp. · 2013
- Descendant · 4 generations on · 3 of its ownK222304 Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K173703Sonata Sonography-Guided Transcervical Fibroid Ablation SystemGynesonics, Inc. · 2018 · cites it directly6descendants
- K193516Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1Gynesonics, Inc. · 2020 · 2 generations on5descendants
- K211535Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2021 · 3 generations on4descendants
- K131209Terason USMART3200T Ultrasound SystemTeratech Corp. · 2013 · cites it directly4descendants
- K222304Sonata Transcervical Fibroid Ablation System 2.2Gynesonics, Inc. · 2022 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K934041 | Hewlett Packard Conos Ultrasound Imaging System Modification | Hewlett-Packard Co. | 1994 | — |
| −4 | K964309 | Sonos 2000, Sonos 2500 (M2406 a) | Hewlett-Packard Co. | 1997 | — |
| −3 | K982800 | Ecton Lynx Ultrasound System | Ecton, Inc. | 1998 | — |
| −2 | K021497 | Cypress Ultrasound System | Acuson Corp. | 2002 | 2 |
| −1 | K080234 | Terason Echo T/3000 Ultrasound System with Stress Echo | Teratech Corp. | 2008 | — |
| 0 (this device) | K110020 | Terason T3200 Ultrasound System | Teratech Corp. | 2011 | — |
| +1 | K173703 | Sonata Sonography-Guided Transcervical Fibroid Ablation System | Gynesonics, Inc. | 2018 | — |
| +2 | K193516 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 | Gynesonics, Inc. | 2020 | — |
| +3 | K211535 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2021 | — |
| +1 | K131209 | Terason USMART3200T Ultrasound System | Teratech Corp. | 2013 | — |
| +4 | K222304 | Sonata Transcervical Fibroid Ablation System 2.2 | Gynesonics, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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 |
|---|---|---|---|
| * | K080234 | Terason Echo T/3000 Ultrasound System with Stress EchoSummary page 1…Imaging System (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX) 3. Predicate Device TerasonTM Echo/t3000 Ultrasound System (K080234) 4. Intended Use The Teratech Corporation Terason TM t3200 is a general purpose Ultrasound. System intended for use by a qua… | 2008 |
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K173703 (Gynesonics, Inc., 2018) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K080234.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The subject-modified device is a general purpose Ultrasound System intended for use by a qualified phiysician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal: Abdominal; Intro-operative (abdominal, thoracic and PV): Laparosopic; Pediatric: Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Trans-rectal and Trans-vaginal: Musculo-skeletal Conventional and Superficial; Cardiac (adult & pediatic); Peripheral Vascular.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110020 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110020: Terason T3200 Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110020
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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