510(k) · Cleared
ClearedEub-5500 Diagnostic Ultrasound Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Medical Systems America, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 22, 2003 after a 9-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- Aug 22, 2003
- Review
- 9 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK032503 Eub-5500 Diagnostic Ultrasound ScannerHitachi Medical Systems America, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK041395 EG-3630URPentax Precision Instrument Corp. · 2004
- Descendant · cites it directly · 3 of its ownK061068 EG-3670URKPentax Medical Company · 2006 · Recalled
- Descendant · 2 generations on · 2 of its ownK090196 EG-3670URKPentax Medical Company · 2009 · Recalled
- Descendant · 3 generations on · 1 of its ownK130206 Pentax EG-3670URK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc. · 2013
- Descendant · 4 generations on · 0 of its ownK231813 Ultrasonic GastrovideoscopeSonoscape Medical Corp. · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K041395EG-3630URPentax Precision Instrument Corp. · 2004 · cites it directly4descendants
- K061068EG-3670URKPentax Medical Company · 2006 · cites it directly3descendants
- K090196EG-3670URKPentax Medical Company · 2009 · 2 generations on2descendants
- K130206Pentax EG-3670URK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc. · 2013 · 3 generations on1descendant
- K231813Ultrasonic GastrovideoscopeSonoscape Medical Corp. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032503 | Eub-5500 Diagnostic Ultrasound Scanner | Hitachi Medical Systems America, Inc. | 2003 | — |
| +1 | K041395 | EG-3630UR | Pentax Precision Instrument Corp. | 2004 | — |
| +1 | K061068 | EG-3670URK | Pentax Medical Company | 2006 | 1 |
| +2 | K090196 | EG-3670URK | Pentax Medical Company | 2009 | 1 |
| +3 | K130206 | Pentax EG-3670URK Ultrasound Video Gastroscope + HI Vision Preirus | Pentax of America, Inc. | 2013 | — |
| +4 | K231813 | Ultrasonic Gastrovideoscope | Sonoscape Medical Corp. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2024 | 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K041395 (Pentax Precision Instrument Corp., 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032503 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032503: Eub-5500 Diagnostic Ultrasound Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032503
Report an extraction error
Are you the manufacturer?
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