510(k) · Cleared
ClearedSeeker/Spark Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ardent Sound, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 7, 2006 as substantially equivalent to K013142 (Dynamic Imaging, Ltd., 2001) and 2 other predicates after a 14-day review. Its family tree reaches back 4 generations to 1995. 2 later devices descend from it.
- Decided
- Apr 7, 2006
- Review
- 14 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K944485 (1995). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK944485 4000 AU Ultrasound Imaging SystemBiosound, Inc. · 1995
- 3 generations backK980468 AU5 Ultrasound Imaging SystemBiosound Esaote, Inc. · 1998
- 2 generations backK990360 AU6Biosound Esaote, Inc. · 1999
- 1 generation backK013142 DiasusDynamic Imaging, Ltd. · 2001
- This deviceK060800 Seeker/Spark Ultrasound SystemArdent Sound, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK102253 Echo BlasterTelemed · 2011
- Descendant · 2 generations on · 0 of its ownK161968 MicrUsTelemed · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944485 | 4000 AU Ultrasound Imaging System | Biosound, Inc. | 1995 | — |
| −3 | K980468 | AU5 Ultrasound Imaging System | Biosound Esaote, Inc. | 1998 | — |
| −2 | K990360 | AU6 | Biosound Esaote, Inc. | 1999 | — |
| −1 | K013142 | Diasus | Dynamic Imaging, Ltd. | 2001 | — |
| 0 (this device) | K060800 | Seeker/Spark Ultrasound System | Ardent Sound, Inc. | 2006 | — |
| +1 | K102253 | Echo Blaster | Telemed | 2011 | — |
| +2 | K161968 | MicrUs | Telemed | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 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? (3)
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 |
|---|---|---|---|
| * | K013142 | DiasusSummary page 1…ce claimed to: Trade Name Manufacturer 510(k) DIASUS Dynamic Imaging Ltd K013142 AU5 Esaote K980468 AU5/3D Esaote… | 2001 |
| * | K980468 | AU5 Ultrasound Imaging SystemSummary page 1…510(k) DIASUS Dynamic Imaging Ltd K013142 AU5 Esaote K980468 AU5/3D Esaote K000681 The Seeker/Spark is of comparable type and sub… | 1998 |
| * | K000681 | AU5, AU6Summary page 1…K013142 AU5 Esaote K980468 AU5/3D Esaote K000681 The Seeker/Spark is of comparable type and substantially equivalent to the legally marketed 510(k) Summary of Safety and Effecti… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102253 | Echo Blaster | 2011 | 1 |
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?
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?
B and M-mode imaging for: Fetal, Abdominal, 3-D Visualization (non-measuring), Small organ, Pediatric, Cephalic, Transrectal, Transvaginal, Musculoskeletal (conventional and superficial), Peripheral Vessel and Needle Guidance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060800 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060800: Seeker/Spark Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060800
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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