510(k) · Cleared
ClearedESI-5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elscint, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jun 12, 1996 after a 966-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jun 12, 1996
- Review
- 966 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK935024 ESI-5000Elscint, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK972973 Perception Inc. GPS-Tuv Diagnostic Ultrasound SystemPerception, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK981834 Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK974880 Perception GPS-RST Diagnostic Ultrasound SystemPerception, Inc. · 1998
Most influential descendants
Showing 3 of 3 · See all- K972973Perception Inc. GPS-Tuv Diagnostic Ultrasound SystemPerception, Inc. · 1997 · cites it directly2descendants
- K981834Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc. · 1998 · cites it directly0descendants
- K974880Perception GPS-RST Diagnostic Ultrasound SystemPerception, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935024 | ESI-5000 | Elscint, Inc. | 1996 | — |
| +1 | K972973 | Perception Inc. GPS-Tuv Diagnostic Ultrasound System | Perception, Inc. | 1997 | — |
| +1 | K981834 | Perception Inc, GPS-6TBMD Diagnostic Ultrasound System | Perception, Inc. | 1998 | — |
| +1 | K974880 | Perception GPS-RST Diagnostic Ultrasound System | Perception, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | — | ESI-1000 Named without a submission number | |
| * | — | ESI-2000 Named without a submission number | |
| * | — | ESI-3000 Named without a submission number | |
| * | — | 128 XP Named without a submission number | |
| * | — | UM-9 Named without a submission number |
What descends from it? (3)
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, K972973 (Perception, Inc., 1997) has gone furthest, with 2 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?
The ESI-5000 ultrasound system main applications are in general radiology, obstetrics/gynecology, cardiology, and peripheral vessel 2D imaging, spectral Doppler analysis, and color Doppler imaging.
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/K935024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935024: ESI-5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935024
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