510(k) · Cleared
ClearedEnovare Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oreon Technologies, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 5, 2016 as substantially equivalent to K123254 (B-K Medical Aps, 2013) and 1 other predicate after a 139-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- May 5, 2016
- Review
- 139 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K000567 (2000). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK000567 Ultrasound Scanner Type 2102B & K Medical A/S · 2000 · Recalled
- 4 generations backK024236 Ultrasound Scanner, Type 2400B-K Medical A/S · 2003 · Recalled
- 3 generations backK043524 Ultrasound Scanner Pro Focus, Model 2202B-K Medical A/S · 2005 · Recalled
- 2 generations backK081154 Ultrasound Scanner Flex Focus, Model 1202B-K Medical Aps · 2008
- 1 generation backK123254 Ultrasound Scanner Flex FocusB-K Medical Aps · 2013
- This deviceK153620 Enovare Ultrasound SystemOreon Technologies, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000567 | Ultrasound Scanner Type 2102 | B & K Medical A/S | 2000 | 1 |
| −4 | K024236 | Ultrasound Scanner, Type 2400 | B-K Medical A/S | 2003 | 2 |
| −3 | K043524 | Ultrasound Scanner Pro Focus, Model 2202 | B-K Medical A/S | 2005 | 1 |
| −2 | K081154 | Ultrasound Scanner Flex Focus, Model 1202 | B-K Medical Aps | 2008 | — |
| −1 | K123254 | Ultrasound Scanner Flex Focus | B-K Medical Aps | 2013 | — |
| 0 (this device) | K153620 | Enovare Ultrasound System | Oreon Technologies, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2011 | 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? (2)
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 |
|---|---|---|---|
| * | K123254 | Ultrasound Scanner Flex FocusSummary page 8…maging System (90 IYN, CFR 892.1560) Diagnostic Ultrasound Transducer (90 ITX, CFR 892.1570) Regulatory Class: II II1. PREDICATE DEVICES B & K Medical Flex Focus 1202, K123254 3G Ultrasound Sonalis K043189 IV. DEVICE DESCRIPTION The Enovare supports the following scanning modes and combinations thereo… | 2013 |
| * | K043189 | Sonalis, Model 2000Summary page 8…1560) Diagnostic Ultrasound Transducer (90 ITX, CFR 892.1570) Regulatory Class: II II1. PREDICATE DEVICES B & K Medical Flex Focus 1202, K123254 3G Ultrasound Sonalis K043189 IV. DEVICE DESCRIPTION The Enovare supports the following scanning modes and combinations thereof: B-mode (incl. Tissue Harmoni… | 2005 |
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 16 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 3 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K123254.
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?
The Enovare system’s ultrasound scanner connected with a probe enables real time diagnostic ultrasound imaging for B-mode, Tissue and Contrast Harmonic Imaging, PWD, Power Doppler, Color Doppler and combined mode imaging. Signal Analysis and display. Guidance of biopsy and therapy needles, geometrical measurements and calculation of parameters.
The system offers optional probes each type optimized to image structure and orientation of tissues during specific clinical applications. These include general Abdominal, Intraoperative, Cardiac, Neurosurgery, Transrectal, Small organs, Urological, Transvaginal, Musculoskeletal.
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/K153620 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153620: Enovare 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/K153620
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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