510(k) · Cleared
ClearedEZONO 4000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ezono AG · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Feb 26, 2014 as substantially equivalent to K120234 (Life-Tech, Inc., 2012) and 2 other predicates after a 26-day review. Its family tree reaches back 8 generations to 1994. 6 of the 104 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.
- Decided
- Feb 26, 2014
- Review
- 26 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K911783 (1994). 90 ancestors in all, the oldest K844472 (1985). 13 later devices descend from it, 2 citing it directly. 6 of the 104 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 7 generations backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
- 6 generations backK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
- 5 generations backK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
- 4 generations backK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- 3 generations backK080624 Navstationirad Emt, Version 1.1Cas Innovations AG · 2008
- 2 generations backK092619 Etrax Needle System, Etrax Variable Angle Needle Guidance System…Civco · 2009 · Recalled
- 1 generation backK111818 Sonixgps Needle SensorUltrasonix Medical Corporation · 2012
- This deviceK140254 EZONO 4000Ezono AG · 2014
- Descendant · cites it directly · 10 of its ownK182894 HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2019
- Descendant · 2 generations on · 9 of its ownK191055 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2019
- Descendant · 3 generations on · 8 of its ownK200339 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2020
- Descendant · 4 generations on · 4 of its ownK210713 HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2021
- Descendant · 5 generations on · 3 of its ownK220269 HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2019 · cites it directly10descendants
- K191055HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2019 · 2 generations on9descendants
- K200339HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2020 · 3 generations on8descendants
- K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2021 · 4 generations on4descendants
- K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2022 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −7 | K981998 | Pediatric Instatrak System | Visualization Technology, Inc. | 1998 | Class I |
| −6 | K983529 | Instatrak 3000 | Visualization Technology, Inc. | 1998 | Class I |
| −5 | K994270 | Instatrak 3000 System with Fluorotrak Module, Model IT3000 | Visualization Technology, Inc. | 2000 | Class I |
| −4 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| −3 | K080624 | Navstationirad Emt, Version 1.1 | Cas Innovations AG | 2008 | — |
| −2 | K092619 | Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax… | Civco | 2009 | 17 |
| −1 | K111818 | Sonixgps Needle Sensor | Ultrasonix Medical Corporation | 2012 | — |
| 0 (this device) | K140254 | EZONO 4000 | Ezono AG | 2014 | — |
| +1 | K182894 | HM70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019 | — |
| +2 | K191055 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019 | — |
| +3 | K200339 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020 | — |
| +4 | K210713 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021 | — |
| +5 | K220269 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 1 |
| 1997 | 6 | 0 |
| 1998 | 8 | 1 |
| 1999 | 9 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 9 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 1 |
| 2005 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
6 devices in this family have a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | K120234 | EZONO 3000Summary page 1…Regulatory Class: Class 11 Classification Panel: Radiology Predicate Device(s): eZono Tm 3000 Series Ultrasound System (K120234) Terason t3000 Ultrasound Systems With Updated Needle Guidance… | 2012 |
| * | K112953 | Terason T3000 Ultrasound Systems with Updated Needle Guidance GraphicsSummary page 1…tem (K120234) Terason t3000 Ultrasound Systems With Updated Needle Guidance Graphics (K1 12953) Ultrasonix Sonixgps Needle Sensor (K1 11818)… | 2012 |
| * | K111818 | Sonixgps Needle SensorSummary page 1…s With Updated Needle Guidance Graphics (K1 12953) Ultrasonix Sonixgps Needle Sensor (K1 11818) SonoSite M-Turbo (1130173) Intended Use/ Diagnostic ultras… | 2012 |
| Kept off the family tree | K1130173 | SonoSite M-Turbo Number could not be read Summary page 1…Graphics (K1 12953) Ultrasonix Sonixgps Needle Sensor (K1 11818) SonoSite M-Turbo (1130173) Intended Use/ Diagnostic ultrasound imaging or fluid flow analysis of the human body.… |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 4 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 4 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 25 of the 90 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K182894 (Samsung Medison Co., Ltd., 2019) has gone furthest, with 10 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) | — |
What is it indicated for?
Intended Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications For Use:
The indications for use of the eZonotm 4000. as defined by FDA guidance documents, are:
Fetal, Abdominal, Pediatric. Small Organ (breast, thyroid, testicle). Musculo-skeletal (Conventional). Musculo-skeletal (Superficial), Invasive diagnostic or therapeutic procedures. Retroperitoneum. Female reproductive system and fetus. Superficial structures & pathologies. Peripheral Vessel. Magnetic Needle guidance
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140254: EZONO 4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140254
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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