510(k) · Cleared
ClearedMorpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Prometheus Group · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 15, 2016 as substantially equivalent to K070907 (Regulatory Management Services, 2007) after a 23-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Apr 15, 2016
- Review
- 23 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K903603 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK903603 Ultramark 9 Ultrasound System (UM 9)Advanced Technology Laboratories, Inc. · 1991
- 2 generations backK992505 Teratech, Model 2000 Imaging ImagingTeratech Corp. · 1999
- 1 generation backK070907 Interson Usb Ultrasound Probe SystemRegulatory Management Services · 2007
- This deviceK160792 Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan…The Prometheus Group · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903603 | Ultramark 9 Ultrasound System (UM 9) | Advanced Technology Laboratories, Inc. | 1991 | — |
| −2 | K992505 | Teratech, Model 2000 Imaging Imaging | Teratech Corp. | 1999 | — |
| −1 | K070907 | Interson Usb Ultrasound Probe System | Regulatory Management Services | 2007 | — |
| 0 (this device) | K160792 | Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder… | The Prometheus Group | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 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 |
|---|---|---|---|
| * | K070907 | Interson Usb Ultrasound Probe SystemSummary page 5…Intra-cardiac Other (Specify) Peripheral Peripheral vessel Vessel Other (Specify) P = previously cleared by FDA, K070907 Note 1: Abdominal - Pelvic, Solid Organs, Aneurysms, Bladder Note 2: Small Organ - Testes, Prostate Prescriptive Use (Part 21… | 2007 |
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 25 years and passes through 4 companies; a new generation was cleared every 8.7 years on median.
- None of the 5 ancestors has a recall.
- 6 other devices also cite its predicate K070907.
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?
Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, QuickScan® Bladder Ultrasound are diagnostic ultrasound systems designed to be used for general pelvic imaging. An ultrasonographic crystal within the probe records images of the organ, muscle, and tissue structures of the pelvic region. Measurements and calculations of the organ, muscle, and tissue structures can be recorded.
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/K160792 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160792: Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160792
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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