510(k) · Cleared
ClearedEchoSK and EchoSGyn modules for EchoS Family devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Echolight S.P.A · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Mar 16, 2022 as substantially equivalent to K202683 (Siemens Medical Solutions USA, Inc., 2020) and 1 other predicate after a 190-day review. Its family tree reaches back 29 generations to 1995.
- Decided
- Mar 16, 2022
- Review
- 190 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 29 generations to K935595 (1995). 287 ancestors in all, the oldest K810116 (1981). No later device cites it as a predicate yet.
- Root · 29 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 25 generations between
- 3 generations backK200707 ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020
- 2 generations backK201462 ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- 1 generation backK202683 ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000…Siemens Medical Solutions USA, Inc. · 2020
- This deviceK212851 EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A · 2022
Show all 29 generations
- Root · 29 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 28 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 27 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 26 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 25 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 24 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 23 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 22 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 21 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 20 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 19 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 18 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 17 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 16 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 15 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 14 generations backK121699 Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic…Siemens Medical Solutions USA, Inc. · 2012
- 13 generations backK123001 Acuson X700 Diagnstic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2012 · Recalled
- 12 generations backK132804 Acuson S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013 · Recalled
- 11 generations backK140959 Acuson S1000, S2000, S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014
- 10 generations backK142876 ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- 9 generations backK152369 ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemSiemens Medical Solutions USA, Inc. Ultrasound Group · 2015
- 8 generations backK162243 ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound SystemSiemens Medi Cal Solutions, Inc. · 2016
- 7 generations backK163635 ACUSON S1000/S2000/S3000 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. Ultrasound Group · 2017 · Recalled
- 6 generations backK172162 ACUSON S3000 S2000 S1000 Diagnostic Ultrasound SystemsSiemens Healthcare · 2017
- 5 generations backK180067 ACUSON X800 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2018
- 4 generations backK193257 ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- 3 generations backK200707 ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020
- 2 generations backK201462 ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- 1 generation backK202683 ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000…Siemens Medical Solutions USA, Inc. · 2020
- This deviceK212851 EchoSK and EchoSGyn modules for EchoS Family devicesEcholight S.P.A · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −29 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −28 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −27 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −26 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −25 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −24 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −23 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −22 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −21 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −20 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −19 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −18 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −17 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −16 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −15 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −14 | K121699 | Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound… | Siemens Medical Solutions USA, Inc. | 2012 | — |
| −13 | K123001 | Acuson X700 Diagnstic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2012 | 2 |
| −12 | K132804 | Acuson S1000 / S2000 / S3000 | Siemens Medical Solutions USA, Inc. Ultrasound Gro | 2013 | 3 |
| −11 | K140959 | Acuson S1000, S2000, S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −10 | K142876 | ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2014 | 1 |
| −9 | K152369 | ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2015 | — |
| −8 | K162243 | ACUSON S1000 / S2000 / S3000 Diagnostic Ultrasound System | Siemens Medi Cal Solutions, Inc. | 2016 | — |
| −7 | K163635 | ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. Ultrasound Group | 2017 | 1 |
| −6 | K172162 | ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems | Siemens Healthcare | 2017 | — |
| −5 | K180067 | ACUSON X800 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2018 | — |
| −4 | K193257 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| −3 | K200707 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | — |
| −2 | K201462 | ACUSON Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| −1 | K202683 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic… | Siemens Medical Solutions USA, Inc. | 2020 | — |
| 0 (this device) | K212851 | EchoSK and EchoSGyn modules for EchoS Family devices | Echolight S.P.A | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 8 | 0 |
| 1996 | 6 | 0 |
| 1997 | 10 | 0 |
| 1998 | 11 | 0 |
| 1999 | 9 | 0 |
| 2000 | 10 | 0 |
| 2001 | 11 | 0 |
| 2002 | 14 | 0 |
| 2003 | 16 | 0 |
| 2004 | 18 | 0 |
| 2005 | 15 | 0 |
| 2006 | 10 | 0 |
| 2007 | 12 | 0 |
| 2008 | 12 | 0 |
| 2009 | 12 | 0 |
| 2010 | 11 | 0 |
| 2011 | 5 | 0 |
| 2012 | 8 | 0 |
| 2013 | 7 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K202683 | ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System…Summary page 4…ACUSON Freestyle Diagnostic Ultrasound System, ACUSON S1000, S2000, S3000 Diagnostic Siemens Medical K202683 21 CFR 892.1550 Ultrasound Systems, ACUSON P200 Diagnostic Solutions, USA, Inc.… | 2020 |
| * | K202514 | EchoS FamilySummary page 4…Legally Marketed Additional Predicate Device 510(k) Pro Code Trade Name Applicant Number K202514 21 CFR 892.1180 EchoS Family Echolight S.p.a. 510(k) Premarket No… | 2021 |
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 27 years and passes through 10 companies; a new generation was cleared every 9 months on median.
- 73 of the 287 ancestors have a recall of any class.
- 1 other device also cites its predicate K202683.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
1) EchoSK and EchoSGyn Modules are additional software/hardware modules for EchoS Family devices and they are additions in terms of indication for use of the legally marketed EchoS Family. 2) EchoSK optional module for EchoS Family devices is intended to provide images of, or signals from, inside the body acquired by an appropriately trained professional in a clinical setting for musculoskeletal applications. The EchoSK module can be used both with a…
Read the full statement (137 words)
1) EchoSK and EchoSGyn Modules are additional software/hardware modules for EchoS Family devices and they are additions in terms of indication for use of the legally marketed EchoS Family.
2) EchoSK optional module for EchoS Family devices is intended to provide images of, or signals from, inside the body acquired by an appropriately trained professional in a clinical setting for musculoskeletal applications. The EchoSK module can be used both with a convex or a linear probe.
3) EchoSGyn optional module for EchoS Family devices is intended to provide images of, or signals from, inside the body acquired by an appropriately-trained professional in a clinical setting for Fetal and OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures) applications. The EchoSGyn module can be used both with a convex or with an endocavitary probe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212851: EchoSK and EchoSGyn modules for EchoS Family devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212851
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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