510(k) · Cleared
ClearedEZONO 3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life-Tech, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Apr 19, 2012 after an 85-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 14 later devices descend from it.
- Decided
- Apr 19, 2012
- Review
- 85 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 1 citing it directly.
- This deviceK120234 EZONO 3000Life-Tech, Inc. · 2012
- Descendant · cites it directly · 13 of its ownK140254 EZONO 4000Ezono AG · 2014
- Descendant · 2 generations on · 10 of its ownK182894 HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2019
- Descendant · 3 generations on · 9 of its ownK191055 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2019
- Descendant · 4 generations on · 8 of its ownK200339 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2020
- Descendant · 5 generations on · 4 of its ownK210713 HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K140254EZONO 4000Ezono AG · 2014 · cites it directly13descendants
- K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2019 · 2 generations on10descendants
- K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2019 · 3 generations on9descendants
- K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2020 · 4 generations on8descendants
- K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2021 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K120234 | EZONO 3000 | Life-Tech, Inc. | 2012 | — |
| +1 | K140254 | EZONO 4000 | Ezono AG | 2014 | — |
| +2 | K182894 | HM70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019 | — |
| +3 | K191055 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019 | — |
| +4 | K200339 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020 | — |
| +5 | K210713 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140254 | EZONO 4000 | 2014 | 13 |
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, K140254 (Ezono AG, 2014) has gone furthest, with 13 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. 2012, 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 intended use of the eZono 3000, as defined by FDA guidance documents, are:
Ophthalmic
Fetal (as enumerated in the IFU Tables)
Abdominal
Pediatric
Small Organ (breast, thyroid, testicle)
Invasive diagnostic or therapeutic procedures
Peripheral vessel
Musculo-skeletal (Conventional)
Musculo-skeletal (Superficial)
Retroperitoneum
Female reproductive system and foetus
Cardiac (Adult)
Cardiac (Pediatric)
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K120234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120234: EZONO 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120234
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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