510(k) · Cleared
ClearedEcho Blaster
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Telemed · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Mar 14, 2011 as substantially equivalent to K050551 (Ardent Sound, Inc., 2005) and 2 other predicates after a 217-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Mar 14, 2011
- Review
- 217 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K944485 (1995). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK944485 4000 AU Ultrasound Imaging SystemBiosound, Inc. · 1995
- 4 generations backK980468 AU5 Ultrasound Imaging SystemBiosound Esaote, Inc. · 1998
- 3 generations backK990360 AU6Biosound Esaote, Inc. · 1999
- 2 generations backK013142 DiasusDynamic Imaging, Ltd. · 2001
- 1 generation backK050551 Voyager Personal Imaging DeviceArdent Sound, Inc. · 2005
- This deviceK102253 Echo BlasterTelemed · 2011
- Descendant · cites it directly · 0 of its ownK161968 MicrUsTelemed · 2016
Most influential descendants
Showing 1 of 1 · See all- K161968MicrUsTelemed · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944485 | 4000 AU Ultrasound Imaging System | Biosound, Inc. | 1995 | — |
| −4 | K980468 | AU5 Ultrasound Imaging System | Biosound Esaote, Inc. | 1998 | — |
| −3 | K990360 | AU6 | Biosound Esaote, Inc. | 1999 | — |
| −2 | K013142 | Diasus | Dynamic Imaging, Ltd. | 2001 | — |
| −1 | K050551 | Voyager Personal Imaging Device | Ardent Sound, Inc. | 2005 | — |
| 0 (this device) | K102253 | Echo Blaster | Telemed | 2011 | — |
| +1 | K161968 | MicrUs | Telemed | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K050551 | Voyager Personal Imaging DeviceSummary page 1…und imaging system Propietary Name Echo Blaster Class Regulatory Class 11 Predicate Devices Ardent Sound, Inc.; Voyager K050551 Ardent Sound, Inc.; Seeker/Spark K060800 Medison America, Inc;… | 2005 |
| * | K060800 | Seeker/Spark Ultrasound SystemSummary page 1…Class 11 Predicate Devices Ardent Sound, Inc.; Voyager K050551 Ardent Sound, Inc.; Seeker/Spark K060800 Medison America, Inc; MYSONO 201 K003121 3. Performance Standards Performance Sta… | 2006 |
| * | K003121 | Mysono 201 Diagnostic Ultrasound and TransducersSummary page 1…K050551 Ardent Sound, Inc.; Seeker/Spark K060800 Medison America, Inc; MYSONO 201 K003121 3. Performance Standards Performance Standards None The Echo Blaster family has been designed to meet the following:… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161968 | MicrUs | 2016 | 0 |
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 16 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K161968 (Telemed, 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K050551.
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. 2011, 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?
Echo Blaster 128 1 Echo Blaster 64 ultrasound imaging systems are intended to be used for applications in fetal, abdominal, pediatriq small organ (breast, thyroid and testicles), cephalic (neonatal and adult). musculoskeletal (conventional), musculoskeletal (superficial), cardiac adult and peripheral vessel (including imaging for needle guidance, see chiS.). It is possible to provide diagnostic information (B, B+M and M-mode imaging) outside of an imaging lab, including at the bedside systems, for navigated medical application, inoperating rooms/critical care units.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102253: Echo Blaster.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102253
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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