510(k) · Cleared
ClearedTerason USMART3300 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 30, 2014 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 30, 2014
- Review
- 63 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK140773 Terason USMART3300 Ultrasound SystemTeratech Corp. · 2014
- Descendant · cites it directly · 2 of its ownK150533 Terason uSmart3200T Ultrasound SystemTeratech Corp. · 2015
- Descendant · 2 generations on · 1 of its ownK193510 Terason uSmart3200T Ultrasound SystemTeratech Corporation · 2020
- Descendant · 3 generations on · 0 of its ownK201633 Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation · 2020
- Descendant · cites it directly · 0 of its ownK150148 Terason uSmart3300 Ultrasound SystemTeratech Corp. · 2015
Most influential descendants
Showing 4 of 4 · See all- K150533Terason uSmart3200T Ultrasound SystemTeratech Corp. · 2015 · cites it directly2descendants
- K193510Terason uSmart3200T Ultrasound SystemTeratech Corporation · 2020 · 2 generations on1descendant
- K201633Terason uSmart 3200T Plus Ultrasound SystemTeratech Corporation · 2020 · 3 generations on0descendants
- K150148Terason uSmart3300 Ultrasound SystemTeratech Corp. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K140773 | Terason USMART3300 Ultrasound System | Teratech Corp. | 2014 | — |
| +1 | K150533 | Terason uSmart3200T Ultrasound System | Teratech Corp. | 2015 | — |
| +2 | K193510 | Terason uSmart3200T Ultrasound System | Teratech Corporation | 2020 | — |
| +3 | K201633 | Terason uSmart 3200T Plus Ultrasound System | Teratech Corporation | 2020 | — |
| +1 | K150148 | Terason uSmart3300 Ultrasound System | Teratech Corp. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2020 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 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?
- Of its descendants, K150533 (Teratech Corp., 2015) has gone furthest, with 2 descendants of its own.
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) | — |
https://510kreport.com/device/K140773 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140773: Terason USMART3300 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/K140773
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026