510(k) · Cleared
ClearedMYLAB30, Model 7300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Esaote, S.p.A. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Aug 3, 2007 as substantially equivalent to K040596 (Esaote, S.p.A., 2004) and 3 other predicates after an 8-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Aug 3, 2007
- Review
- 8 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K944485 (1995). 62 ancestors in all, the oldest K850478 (1985). No later device cites it as a predicate yet.
- Root · 8 generations backK944485 4000 AU Ultrasound Imaging SystemBiosound, Inc. · 1995
- 7 generations backK980468 AU5 Ultrasound Imaging SystemBiosound Esaote, Inc. · 1998
- 6 generations backK990360 AU6Biosound Esaote, Inc. · 1999
- 5 generations backK014168 AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D…Biosound Esaote, Inc. · 2002
- 4 generations backK040596 Ultrasound Imaging System, Model 7300Esaote, S.p.A. · 2004 · Recalled
- 3 generations backK050326 7350 Ultrasound Imaging System, Model 7350Esaote, S.p.A. · 2005 · Recalled
- 2 generations backK051308 Mylab 70 Ultrasound Imaging SystemEsaote, S.p.A. · 2005
- 1 generation backK052805 MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150Esaote, S.p.A. · 2005
- This deviceK071996 MYLAB30, Model 7300Esaote, S.p.A. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K944485 | 4000 AU Ultrasound Imaging System | Biosound, Inc. | 1995 | — |
| −7 | K980468 | AU5 Ultrasound Imaging System | Biosound Esaote, Inc. | 1998 | — |
| −6 | K990360 | AU6 | Biosound Esaote, Inc. | 1999 | — |
| −5 | K014168 | AU6 (Technos/Technos MP) Ultrasound Imaging System (Addition of 3D Imaging… | Biosound Esaote, Inc. | 2002 | — |
| −4 | K040596 | Ultrasound Imaging System, Model 7300 | Esaote, S.p.A. | 2004 | 4 |
| −3 | K050326 | 7350 Ultrasound Imaging System, Model 7350 | Esaote, S.p.A. | 2005 | 1 |
| −2 | K051308 | Mylab 70 Ultrasound Imaging System | Esaote, S.p.A. | 2005 | — |
| −1 | K052805 | MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150 | Esaote, S.p.A. | 2005 | — |
| 0 (this device) | K071996 | MYLAB30, Model 7300 | Esaote, S.p.A. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 8 | 0 |
| 2000 | 7 | 0 |
| 2001 | 5 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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 IYO? 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? (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 |
|---|---|---|---|
| * | K040596 | Ultrasound Imaging System, Model 7300Summary page 1…rasonic pulsed echo imaging system 892.1560 Classification Number: 9OLYN; 901Y0 807.92(a)(3) Predicate Device(s) K040596 K052805 7300 (MyLab3O) Esaote, S.p.A. K060827 K033367… | 2004 |
| * | K052805 | MYLAB30, 50 and 70 Systems Upgrade, Models 7300, 7350, 6150Summary page 1…ho imaging system 892.1560 Classification Number: 9OLYN; 901Y0 807.92(a)(3) Predicate Device(s) K040596 K052805 7300 (MyLab3O) Esaote, S.p.A. K060827 K033367 Mic… | 2005 |
| * | K060827 | MYLAB30, 50, 70 and 90 Systems Addition of 3D/4D, Models 7300, 7350, 6150, 6100Summary page 1…)(3) Predicate Device(s) K040596 K052805 7300 (MyLab3O) Esaote, S.p.A. K060827 K033367 MicroMaxx SonoSite… | 2006 |
| * | K033367 | Titan Ultrasound System, Sonosite Ilook 25 Ultrasound System, 180PLUS Ultrasound System…Summary page 1…Predicate Device(s) K040596 K052805 7300 (MyLab3O) Esaote, S.p.A. K060827 K033367 MicroMaxx SonoSite… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 8 of the 62 ancestors have a recall of any class.
- 5 other devices also cite its predicate K040596.
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. 2007, this device’s year, is highlighted.
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?
Esaote's Model 7300 (MyLab3O) 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, Pediatric,
Intraoperative: Abdominal, and Other: Urologic. The system provides imaging for
guidance of biopsy and imaging to assist in the placement of needles and catheters in
vascular or other anatomical structures as well as peripheral nerve blocks in
Musculoskeletal applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071996 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071996: MYLAB30, 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/K071996
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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