510(k) · Cleared
ClearedEcton Lynx Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ecton, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Sep 22, 1998 as substantially equivalent to K934041 (Hewlett-Packard Co., 1994) and 3 other predicates after a 43-day review. Its family tree reaches back 2 generations to 1994. 2 of the 904 devices in its family, counting itself, have a Class I recall. 899 later devices descend from it.
- Decided
- Sep 22, 1998
- Review
- 43 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K934041 (1994). 4 ancestors in all, the oldest K891689 (1989). 899 later devices descend from it, 2 citing it directly. 2 of the 904 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK934041 Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co. · 1994
- 1 generation backK964309 Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co. · 1997
- This deviceK982800 Ecton Lynx Ultrasound SystemEcton, Inc. · 1998
- Descendant · cites it directly · 898 of its ownK021497 Cypress Ultrasound SystemAcuson Corp. · 2002 · Recalled
- Descendant · 2 generations on · 827 of its ownK042055 Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- Descendant · 3 generations on · 806 of its ownK052021 V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- Descendant · 4 generations on · 802 of its ownK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- Descendant · 5 generations on · 801 of its ownK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
Showing 5 of 899 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 899 · See all- K021497Cypress Ultrasound SystemAcuson Corp. · 2002 · cites it directly898descendants
- K042055Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · 2 generations on827descendants
- K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · 3 generations on806descendants
- K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · 4 generations on802descendants
- K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · 5 generations on801descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K934041 | Hewlett Packard Conos Ultrasound Imaging System Modification | Hewlett-Packard Co. | 1994 | — |
| −1 | K964309 | Sonos 2000, Sonos 2500 (M2406 a) | Hewlett-Packard Co. | 1997 | — |
| 0 (this device) | K982800 | Ecton Lynx Ultrasound System | Ecton, Inc. | 1998 | — |
| +1 | K021497 | Cypress Ultrasound System | Acuson Corp. | 2002 | 2 |
| +2 | K042055 | Cypress Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| +3 | K052021 | V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| +4 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +5 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 9 | 0 |
| 2010 | 10 | 0 |
| 2011 | 22 | 0 |
| 2012 | 29 | 0 |
| 2013 | 38 | 0 |
| 2014 | 51 | 0 |
| 2015 | 53 | 0 |
| 2016 | 63 | 0 |
| 2017 | 74 | 0 |
| 2018 | 65 | 0 |
| 2019 | 49 | 0 |
| 2020 | 72 | 0 |
| 2021 | 51 | 0 |
| 2022 | 59 | 0 |
| 2023 | 54 | 0 |
| 2024 | 57 | 0 |
| 2025 | 75 | 2 |
| 2026 | 51 | 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.
2 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 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? (5)
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 |
|---|---|---|---|
| * | K934041 | Hewlett Packard Conos Ultrasound Imaging System ModificationSummary page 2…510(k) submission, the legally marketed devices to which we claim substantial equivalence are: Manufacturer Product K Number Hewlett Packard Co. Sonos 2500 Ultrasound K934041 System ATL, Inc. HDI 3000 Ultrasound K935009 System Kontron Miprdfi\Image Processing K891689 System Acuson Corp. Sequoia: Harmo… | 1994 |
| * | K935009 | PegasusSummary page 2…es to which we claim substantial equivalence are: Manufacturer Product K Number Hewlett Packard Co. Sonos 2500 Ultrasound K934041 System ATL, Inc. HDI 3000 Ultrasound K935009 System Kontron Miprdfi\Image Processing K891689 System Acuson Corp. Sequoia: Harmonic K97376 Imaging with Contrast Hewlett Pac… | 1994 |
| * | K891689 | Mipron/UmipronSummary page 2…: Manufacturer Product K Number Hewlett Packard Co. Sonos 2500 Ultrasound K934041 System ATL, Inc. HDI 3000 Ultrasound K935009 System Kontron Miprdfi\Image Processing K891689 System Acuson Corp. Sequoia: Harmonic K97376 Imaging with Contrast Hewlett Packard Co. Sonos 2500: K964309 Harmonic Imaging 4… | 1989 |
| Kept off the family tree | K097376 | Sequoia: Harmonic Imaging with Contrast Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K964309 | Sonos 2000, Sonos 2500 (M2406 a)Summary page 2…Ultrasound K935009 System Kontron Miprdfi\Image Processing K891689 System Acuson Corp. Sequoia: Harmonic K97376 Imaging with Contrast Hewlett Packard Co. Sonos 2500: K964309 Harmonic Imaging 4) Device Description The Ecton Lynx Ultrasound System is a general purpose and cardiac diagnostic ultrasound… | 1997 |
What descends from it? (899)
See all 8992 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K021497 (Acuson Corp., 2002) has gone furthest, with 898 descendants of its own.
- 2 other devices also cite its predicate K934041.
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.
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?
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:
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:
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982800: Ecton Lynx Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982800
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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