510(k) · Cleared
ClearedHdi 5000 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Technology Laboratories, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jun 18, 1999 after a 32-day review. The FDA summary names its predicate without a number. 2 of the 810 devices in its family, counting itself, have a Class I recall. 809 later devices descend from it.
- Decided
- Jun 18, 1999
- Review
- 32 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
809 later devices descend from it, 2 citing it directly. 2 of the 810 devices in this family, counting this one, have a Class I recall.
- This deviceK991671 Hdi 5000 Diagnostic Ultrasound SystemAdvanced Technology Laboratories, Inc. · 1999
- Descendant · cites it directly · 677 of its ownK034003 Hdi 5000 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 676 of its ownK053069 Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · Recalled
- Descendant · 3 generations on · 584 of its ownK080935 Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008
- Descendant · 3 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- Descendant · 4 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
Showing 5 of 809 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 809 · See all- K034003Hdi 5000 Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · cites it directly677descendants
- K053069Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series)Sonosite,Inc. · 2005 · 2 generations on676descendants
- K080935Sonix MDP Ultrasound ScannerUltrasonix Medical Corporation · 2008 · 3 generations on584descendants
- K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 3 generations on582descendants
- K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 4 generations on569descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991671 | Hdi 5000 Diagnostic Ultrasound System | Advanced Technology Laboratories, Inc. | 1999 | — |
| +1 | K034003 | Hdi 5000 Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2004 | 4 |
| +2 | K053069 | Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) | Sonosite,Inc. | 2005 | 3 |
| +3 | K080935 | Sonix MDP Ultrasound Scanner | Ultrasonix Medical Corporation | 2008 | — |
| +3 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| +4 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 15 | 0 |
| 2012 | 28 | 0 |
| 2013 | 34 | 0 |
| 2014 | 44 | 0 |
| 2015 | 51 | 0 |
| 2016 | 61 | 0 |
| 2017 | 68 | 0 |
| 2018 | 59 | 0 |
| 2019 | 44 | 0 |
| 2020 | 62 | 0 |
| 2021 | 50 | 0 |
| 2022 | 51 | 0 |
| 2023 | 49 | 0 |
| 2024 | 55 | 0 |
| 2025 | 68 | 2 |
| 2026 | 46 | 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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | — | General Electric System Five Named without a submission number |
What descends from it? (809)
See all 8092 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K034003 (Philips Ultrasound, Inc., 2004) has gone furthest, with 677 descendants of its own.
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.
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?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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/K991671 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991671: Hdi 5000 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991671
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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