510(k) · Cleared
Recalled · Class II · 2014Ultrasound Imaging System, Model 7300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Esaote, S.p.A. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Mar 31, 2004 as substantially equivalent to K982444 (Biosound Esaote, Inc., 1998) and 3 other predicates after a 23-day review. Its family tree reaches back 4 generations to 1995. 67 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 31, 2004
- Review
- 23 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 4 generations to K944485 (1995). 9 ancestors in all. 67 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK944485 4000 AU Ultrasound Imaging SystemBiosound, Inc. · 1995
- 3 generations backK980468 AU5 Ultrasound Imaging SystemBiosound Esaote, Inc. · 1998
- 2 generations backK990360 AU6Biosound Esaote, Inc. · 1999
- 1 generation backK014168 AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D…Biosound Esaote, Inc. · 2002
- This deviceK040596 Ultrasound Imaging System, Model 7300Esaote, S.p.A. · 2004
- Descendant · cites it directly · 66 of its ownK050326 7350 Ultrasound Imaging System, Model 7350Esaote, S.p.A. · 2005 · Recalled
- Descendant · 2 generations on · 64 of its ownK051837 Mylab 90 Ultrasound Imaging System, Model 6100Esaote, S.p.A. · 2005
- Descendant · 2 generations on · 64 of its ownK051308 Mylab 70 Ultrasound Imaging SystemEsaote, S.p.A. · 2005
- Descendant · cites it directly · 62 of its ownK060827 MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350…Esaote, S.p.A. · 2006
- Descendant · cites it directly · 60 of its ownK052805 MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150Esaote, S.p.A. · 2005
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K0503267350 Ultrasound Imaging System, Model 7350Esaote, S.p.A. · 2005 · cites it directly66descendants
- K051837Mylab 90 Ultrasound Imaging System, Model 6100Esaote, S.p.A. · 2005 · 2 generations on64descendants
- K051308Mylab 70 Ultrasound Imaging SystemEsaote, S.p.A. · 2005 · 2 generations on64descendants
- K060827MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Esaote, S.p.A. · 2006 · cites it directly62descendants
- K052805MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150Esaote, S.p.A. · 2005 · cites it directly60descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944485 | 4000 AU Ultrasound Imaging System | Biosound, Inc. | 1995 | — |
| −3 | K980468 | AU5 Ultrasound Imaging System | Biosound Esaote, Inc. | 1998 | — |
| −2 | K990360 | AU6 | Biosound Esaote, Inc. | 1999 | — |
| −1 | K014168 | AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging… | Biosound Esaote, Inc. | 2002 | — |
| 0 (this device) | K040596 | Ultrasound Imaging System, Model 7300 | Esaote, S.p.A. | 2004 | — |
| +1 | K050326 | 7350 Ultrasound Imaging System, Model 7350 | Esaote, S.p.A. | 2005 | 1 |
| +2 | K051837 | Mylab 90 Ultrasound Imaging System, Model 6100 | Esaote, S.p.A. | 2005 | — |
| +2 | K051308 | Mylab 70 Ultrasound Imaging System | Esaote, S.p.A. | 2005 | — |
| +1 | K060827 | MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100 | Esaote, S.p.A. | 2006 | — |
| +1 | K052805 | MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150 | Esaote, S.p.A. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K982444 | 7250 Ultrasound Imaging SystemSummary page 1…0 IYO 807.92(a)(3) Predicate Device(s) Esaote, S.p.A. 7250 Ultrasound Imaging K982444 System Esaote, S.p.A. 7250 Ultrasound Imaging… | 1998 |
| * | K994369 | 7250 (MEGAS)Summary page 1…maging K982444 System Esaote, S.p.A. 7250 Ultrasound Imaging K994369 System Esaote, S.p.A. Technos Ultrasound… | 2000 |
| * | K014168 | AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging Mode and…Summary page 1…maging K994369 System Esaote, S.p.A. Technos Ultrasound K014 168 Imaging System Philips Medical Systems M2540 Ultrasound Syste… | 2002 |
| * | K014191 | M2540 Diagnostic Ultrasound System, Model M2540Summary page 1…K014 168 Imaging System Philips Medical Systems M2540 Ultrasound System K014191 7 I ok) S mnwrx… | 2002 |
What descends from it? (67)
See all 676 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050326 | 7350 Ultrasound Imaging System, Model 7350 | 2005 | 66 |
| K060827 | MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100 | 2006 | 62 |
| K052805 | MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150 | 2005 | 60 |
| K081794 | Model 7340 Ultrasound System | 2008 | 57 |
| K070903 | MYLAB40 | 2007 | 27 |
| K071996 | MYLAB30, Model 7300 | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 26, 2014 | Class II | Z-2167-2014 | Software design | Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature to exceed the maximum allowable limit. |
| May 6, 2005 | Not classified | Z-1401-05 | Other | Data may be corrupted upon re-opening archived files. |
| May 6, 2005 | Not classified | Z-1403-05 | Other | Data may be corrupted upon re-opening archived files. |
| May 6, 2005 | Not classified | Z-1402-05 | Other | Data may be corrupted upon re-opening archived files. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K050326 (Esaote, S.p.A., 2005) has gone furthest, with 66 descendants of its own.
- 4 other devices also cite its predicate K982444.
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?
Esaote's Model 7300 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal and Pediatric.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040596: Ultrasound Imaging System, Model 7300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040596
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