510(k) · Cleared
ClearedTerason USMART3200T Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teratech Corp. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on May 24, 2013 as substantially equivalent to K112953 (Teratech Corp., 2012) and 1 other predicate after a 25-day review. Its family tree reaches back 6 generations to 1994. 4 later devices descend from it.
- Decided
- May 24, 2013
- Review
- 25 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K934041 (1994). 23 ancestors in all, the oldest K891689 (1989). 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK934041 Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co. · 1994
- 5 generations backK964309 Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co. · 1997
- 4 generations backK982800 Ecton Lynx Ultrasound SystemEcton, Inc. · 1998
- 3 generations backK021497 Cypress Ultrasound SystemAcuson Corp. · 2002 · Recalled
- 2 generations backK080234 Terason Echo T/3000 Ultrasound System with Stress EchoTeratech Corp. · 2008
- 1 generation backK110020 Terason T3200 Ultrasound SystemTeratech Corp. · 2011
- This deviceK131209 Terason USMART3200T Ultrasound SystemTeratech Corp. · 2013
- Descendant · cites it directly · 3 of its ownK140524 Terason USMART3200 and Benq UP200ULTRASOUND SystemTeratech Corp. · 2014
- Descendant · 2 generations on · 2 of its ownK150533 Terason uSmart3200T Ultrasound SystemTeratech Corp. · 2015
- Descendant · 3 generations on · 1 of its ownK193510 Terason uSmart3200T Ultrasound SystemTeratech Corporation · 2020
- Descendant · 4 generations on · 0 of its ownK201633 Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation · 2020
Most influential descendants
Showing 4 of 4 · See all- K140524Terason USMART3200 and Benq UP200ULTRASOUND SystemTeratech Corp. · 2014 · cites it directly3descendants
- K150533Terason uSmart3200T Ultrasound SystemTeratech Corp. · 2015 · 2 generations on2descendants
- K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation · 2020 · 3 generations on1descendant
- K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K934041 | Hewlett Packard Conos Ultrasound Imaging System Modification | Hewlett-Packard Co. | 1994 | — |
| −5 | K964309 | Sonos 2000, Sonos 2500 (M2406 a) | Hewlett-Packard Co. | 1997 | — |
| −4 | K982800 | Ecton Lynx Ultrasound System | Ecton, Inc. | 1998 | — |
| −3 | K021497 | Cypress Ultrasound System | Acuson Corp. | 2002 | 2 |
| −2 | K080234 | Terason Echo T/3000 Ultrasound System with Stress Echo | Teratech Corp. | 2008 | — |
| −1 | K110020 | Terason T3200 Ultrasound System | Teratech Corp. | 2011 | — |
| 0 (this device) | K131209 | Terason USMART3200T Ultrasound System | Teratech Corp. | 2013 | — |
| +1 | K140524 | Terason USMART3200 and Benq UP200ULTRASOUND System | Teratech Corp. | 2014 | — |
| +2 | K150533 | Terason uSmart3200T Ultrasound System | Teratech Corp. | 2015 | — |
| +3 | K193510 | Terason uSmart3200T Ultrasound System | Teratech Corporation | 2020 | — |
| +4 | K201633 | Terason uSmart 3200T Plus Ultrasound System | Teratech Corporation | 2020 | — |
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 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 2 | 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K112953 | Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsSummary page 1…em (21 CFR 892.1560, 90-1YO) Diagnostic Ultrasoni¢ Transducer (21 CFR 892.1570, 90-ITX) . Predicate Devices K 131209 MAY 2 4 2013 Terason™ t3000 Ultrasound System (K112953) and Terason™ t3200 Ultrasound System (K110020) . Device Description The Terason™ uSmarn3200T ultrasound system is equivalent t… | 2012 |
| * | K110020 | Terason T3200 Ultrasound SystemSummary page 1…ni¢ Transducer (21 CFR 892.1570, 90-ITX) . Predicate Devices K 131209 MAY 2 4 2013 Terason™ t3000 Ultrasound System (K112953) and Terason™ t3200 Ultrasound System (K110020) . Device Description The Terason™ uSmarn3200T ultrasound system is equivalent to the previously cleared version of the t3200 an… | 2011 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140524 | Terason USMART3200 and Benq UP200ULTRASOUND System | 2014 | 3 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 23 ancestors have a recall of any class.
- Of its descendants, K140524 (Teratech Corp., 2014) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K112953.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The Teratech Corporation Terason™ uSmart3200T (also known as the BenQ UP200) is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131209 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131209: Terason USMART3200T Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131209
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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