510(k) · Cleared
ClearedUltra Dci Model 5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultrasound Medical Devices, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 21, 2010 as substantially equivalent to K022567 (Acuson Corp., 2002) and 1 other predicate after a 98-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- May 21, 2010
- Review
- 98 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K935595 (1995). 16 ancestors in all, the oldest K921148 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 2 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 1 generation backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- This deviceK100363 Ultra Dci Model 5000Ultrasound Medical Devices, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −2 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −1 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| 0 (this device) | K100363 | Ultra Dci Model 5000 | Ultrasound Medical Devices, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K022567 | Sequoia Signature II Diagnostic Ultrasound SystemSummary page 1…n Name: 21 CFR §892.1560 Ultrasonic Pulsed Echo Imaging System (Product Code IYO) 21 CFR §892.1570 Diagnostic Ultrasound Transducer (Product Code ITX) Predicate Devices: K022567 cleared as the Sequoia Diagnostic Ultrasound System Signature 11and K024236 cleared as the Ultrasound Scanner Type 2400. Device D… | 2002 |
| * | K024236 | Ultrasound Scanner, Type 2400Summary page 1…IYO) 21 CFR §892.1570 Diagnostic Ultrasound Transducer (Product Code ITX) Predicate Devices: K022567 cleared as the Sequoia Diagnostic Ultrasound System Signature 11and K024236 cleared as the Ultrasound Scanner Type 2400. Device Description: The Ultra DCI Model 5000 is a general purpose, mobile, software-… | 2003 |
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 15 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- 4 of the 16 ancestors have a recall of any class.
- 9 other devices also cite its predicate K022567.
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. 2010, 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 Ultra DCI Model 5000 is indicated for use by, or on the order of, a qualified physician for ultrasound imaging of the human heart. The cardiac (adult and pediatric) application using Bmode imaging is supported.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100363: Ultra Dci Model 5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100363
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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