510(k) · Cleared
ClearedTerason USMART3400 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 Apr 25, 2014 as substantially equivalent to K110020 (Teratech Corp., 2011) and 1 other predicate after a 23-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Apr 25, 2014
- Review
- 23 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). No later device cites it as a predicate yet.
- 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 deviceK140834 Terason USMART3400 Ultrasound SystemTeratech Corp. · 2014
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) | K140834 | Terason USMART3400 Ultrasound System | Teratech Corp. | 2014 | — |
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 |
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 |
|---|---|---|---|
| * | K110020 | Terason T3200 Ultrasound SystemSummary page 1…Imaging System (21 CFR 892.1560, 90-IYO) Diagnostic Ultrasonic Transducer (21 CFR 892.1570, 90-ITX) 3. Predicate Devices TerasonTM t3200 Ultrasound System (K1 10020) Terason T3000 Ultrasound System with Needle Guidance (K1 12953). 4. Intended Use The Teratech Corporation TerasonTM uSmar… | 2011 |
| * | K112953 | Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsSummary page 1…ic Transducer (21 CFR 892.1570, 90-ITX) 3. Predicate Devices TerasonTM t3200 Ultrasound System (K1 10020) Terason T3000 Ultrasound System with Needle Guidance (K1 12953). 4. Intended Use The Teratech Corporation TerasonTM uSmart3400 is a general purpose Ultrasound System intended for use by… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 3 of the 23 ancestors have a recall of any class.
- 3 other devices also cite its predicate K110020.
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. 2014, 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™ uSmart3400 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, Pediatric, Small Organ (thyroid, breast, testes), Neonatal Cephalic, Adult Cephalic, Musculoskeletal (conventional and superficial), Cardiac (adult and pediatric), and Peripheral…
Read the full statement (117 words)
The Teratech Corporation Terason™ uSmart3400 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, Pediatric, Small Organ (thyroid, breast, testes), Neonatal Cephalic, Adult Cephalic, Musculoskeletal (conventional and superficial), Cardiac (adult and pediatric), and Peripheral Vascular.
Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging system or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140834 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140834: Terason USMART3400 Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140834
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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