510(k) · Cleared
ClearedMHLX7EC Transducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microhelix, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Sep 22, 2004 as substantially equivalent to K013849 (Tetrad Corp., 2001) and 1 other predicate after a 236-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Sep 22, 2004
- Review
- 236 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K934915 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK934915 Acuson Model 2001Acuson Corp. · 1994
- 2 generations backK991805 Aspen Ultrasound with Freestyle Imaging OptionAcuson Corp. · 1999 · Recalled
- 1 generation backK013849 Tetrad Model TC-EC7-Acp, -L5-, -L7-, -V4-Acp TransducersTetrad Corp. · 2001
- This deviceK040213 MHLX7EC TransducerMicrohelix, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K934915 | Acuson Model 2001 | Acuson Corp. | 1994 | — |
| −2 | K991805 | Aspen Ultrasound with Freestyle Imaging Option | Acuson Corp. | 1999 | 1 |
| −1 | K013849 | Tetrad Model TC-EC7-Acp, -L5-, -L7-, -V4-Acp Transducers | Tetrad Corp. | 2001 | — |
| 0 (this device) | K040213 | MHLX7EC Transducer | Microhelix, Inc. | 2004 | — |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013849 | Tetrad Model TC-EC7-Acp, -L5-, -L7-, -V4-Acp TransducersSummary page 1…II, 892.1570 Legally marketed devices for substantial equivalence comparison: TETRAD TC-EC7-ACP transducer submitted by TETRAD Corporation under 510(k) #K013849 and the Acuson EC7 transducer, which has been submitted several times by Acuson Corporation as part of complete ultrasoun… | 2001 |
| * | K991805 | Aspen Ultrasound with Freestyle Imaging OptionSummary page 1…son EC7 transducer, which has been submitted several times by Acuson Corporation as part of complete ultrasound systems, most recently as part of 510(k) #K991805 for the Aspen System. Description of the device: The Microhelix MHLX7EC is a replacement ultrasound transducer designed t… | 1999 |
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 10 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
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/K040213 · printed Nov 3, 2026
Cite this page
510(k) Report. “K040213: MHLX7EC Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040213
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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