510(k) · Cleared
Recalled · Class III · 2025M2540 Diagnostic Ultrasound System, Model M2540
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jan 7, 2002 after a 17-day review. The FDA summary names its predicate without a number. 70 later devices descend from it. It has been recalled 5 times.
- Decided
- Jan 7, 2002
- Review
- 17 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 5
- Predicates
- 0
70 later devices descend from it, 3 citing it directly.
- This deviceK014191 M2540 Diagnostic Ultrasound System, Model M2540Philips Medical Systems · 2002
- Descendant · cites it directly · 67 of its ownK040596 Ultrasound Imaging System, Model 7300Esaote, S.p.A. · 2004 · Recalled
- Descendant · 2 generations on · 66 of its ownK050326 7350 Ultrasound Imaging System, Model 7350Esaote, S.p.A. · 2005 · Recalled
- Descendant · 3 generations on · 64 of its ownK051837 Mylab 90 Ultrasound Imaging System, Model 6100Esaote, S.p.A. · 2005
- Descendant · 3 generations on · 64 of its ownK051308 Mylab 70 Ultrasound Imaging SystemEsaote, S.p.A. · 2005
- Descendant · 2 generations on · 62 of its ownK060827 MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350…Esaote, S.p.A. · 2006
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 70 · See all- K040596Ultrasound Imaging System, Model 7300Esaote, S.p.A. · 2004 · cites it directly67descendants
- K0503267350 Ultrasound Imaging System, Model 7350Esaote, S.p.A. · 2005 · 2 generations on66descendants
- K051837Mylab 90 Ultrasound Imaging System, Model 6100Esaote, S.p.A. · 2005 · 3 generations on64descendants
- K051308Mylab 70 Ultrasound Imaging SystemEsaote, S.p.A. · 2005 · 3 generations on64descendants
- K060827MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Esaote, S.p.A. · 2006 · 2 generations on62descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K014191 | M2540 Diagnostic Ultrasound System, Model M2540 | Philips Medical Systems | 2002 | — |
| +1 | K040596 | Ultrasound Imaging System, Model 7300 | Esaote, S.p.A. | 2004 | 4 |
| +2 | K050326 | 7350 Ultrasound Imaging System, Model 7350 | Esaote, S.p.A. | 2005 | 1 |
| +3 | K051837 | Mylab 90 Ultrasound Imaging System, Model 6100 | Esaote, S.p.A. | 2005 | — |
| +3 | K051308 | Mylab 70 Ultrasound Imaging System | Esaote, S.p.A. | 2005 | — |
| +2 | K060827 | MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100 | Esaote, S.p.A. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | — | M2410 Ultrasound system with transducers Named without a submission number | |
| * | — | Philips sector, linear and endo-cavity ultrasound transducers Named without a submission number |
What descends from it? (70)
See all 703 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2025 | Class III | Z-1623-2026 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2348-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2387-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| Jul 3, 2025 | Class III | Z-2388-2025 | Device Design | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. |
| May 13, 2005 | Not classified | Z-0923-05 | Other | A defect in the software allows incorrect measurement results to be entered into the system's built-in report. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040596 (Esaote, S.p.A., 2004) has gone furthest, with 67 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014191: M2540 Diagnostic Ultrasound System, Model M2540.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014191
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026