510(k) · Cleared
ClearedTeratech Model 10V5 Smart Probe
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 Apr 14, 2004 as substantially equivalent to K991805 (Acuson Corp., 1999) after a 13-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it.
- Decided
- Apr 14, 2004
- Review
- 13 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K934915 (1994). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK934915 Acuson Model 2001Acuson Corp. · 1994
- 1 generation backK991805 Aspen Ultrasound with Freestyle Imaging OptionAcuson Corp. · 1999 · Recalled
- This deviceK040840 Teratech Model 10V5 Smart ProbeTeratech Corp. · 2004
- Descendant · cites it directly · 1 of its ownK072266 Acuson P50 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK083114 Acuson P50 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934915 | Acuson Model 2001 | Acuson Corp. | 1994 | — |
| −1 | K991805 | Aspen Ultrasound with Freestyle Imaging Option | Acuson Corp. | 1999 | 1 |
| 0 (this device) | K040840 | Teratech Model 10V5 Smart Probe | Teratech Corp. | 2004 | — |
| +1 | K072266 | Acuson P50 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +2 | K083114 | Acuson P50 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K097367 | Acuson 10V4 Sequoia Ultrasound System and Harmonic Imaging Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K991805 | Aspen Ultrasound with Freestyle Imaging OptionSummary page 1…R 892.1570, 90-ITX) 3. PREDICATE DEVICES Acuson 10V4 Sequoia TM Ultrasound System and Harmonic Imaging (K97367) Acuson AspenTM Ultrasound System (K991805) 4. INTENDED USE The TERATECH Model 10V5 Smart Probe is intended for diagnostic ultrasound imaging or fluid flo… | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072266 | Acuson P50 Diagnostic Ultrasound System | 2007 | 1 |
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 10 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K072266 (Siemens Medical Solutions USA, Inc., 2007) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K991805.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040840 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040840: Teratech Model 10V5 Smart Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040840
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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