510(k) · Cleared
ClearedMicrUs
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 Nov 3, 2016 as substantially equivalent to K102253 (Telemed, 2011) after a 108-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Nov 3, 2016
- Review
- 108 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K944485 (1995). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK944485 4000 AU Ultrasound Imaging SystemBiosound, Inc. · 1995
- 5 generations backK980468 AU5 Ultrasound Imaging SystemBiosound Esaote, Inc. · 1998
- 4 generations backK990360 AU6Biosound Esaote, Inc. · 1999
- 3 generations backK013142 DiasusDynamic Imaging, Ltd. · 2001
- 2 generations backK050551 Voyager Personal Imaging DeviceArdent Sound, Inc. · 2005
- 1 generation backK102253 Echo BlasterTelemed · 2011
- This deviceK161968 MicrUsTelemed · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944485 | 4000 AU Ultrasound Imaging System | Biosound, Inc. | 1995 | — |
| −5 | K980468 | AU5 Ultrasound Imaging System | Biosound Esaote, Inc. | 1998 | — |
| −4 | K990360 | AU6 | Biosound Esaote, Inc. | 1999 | — |
| −3 | K013142 | Diasus | Dynamic Imaging, Ltd. | 2001 | — |
| −2 | K050551 | Voyager Personal Imaging Device | Ardent Sound, Inc. | 2005 | — |
| −1 | K102253 | Echo Blaster | Telemed | 2011 | — |
| 0 (this device) | K161968 | MicrUs | Telemed | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2006 | 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? (1)
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 |
|---|---|---|---|
| * | K102253 | Echo BlasterSummary page 10…asound imaging system Propietary Name MicrUs Class Regulatory Class II Predicate Device TELEMED; Echo Blaster K102253 3. Performance Standards The MicrUs has been designed to meet the following: Safety and EMC Requirements for Medical Equ… | 2011 |
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 21 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- None of the 9 ancestors has a recall.
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. 2016, 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?
MicrUs ultrasound imaging system is intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, adult cephalic, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, peripheral vessel (B and M-mode imaging, including imaging for needle guidance). It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.
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/K161968 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161968: MicrUs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161968
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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