510(k) · Cleared
ClearedSonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonosite,Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Aug 12, 2010 as substantially equivalent to K014116 (Sonosite,Inc., 2001) after a 50-day review. Its family tree reaches back 2 generations to 1997. 339 later devices descend from it.
- Decided
- Aug 12, 2010
- Review
- 50 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961459 (1997). 4 ancestors in all. 339 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK961459 Level 10 HdiAdvanced Technology Laboratories, Inc. · 1997
- 1 generation backK014116 Hand-Carried Ultrasound SystemSonosite,Inc. · 2001
- This deviceK101757 Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series…Sonosite,Inc. · 2010
- Descendant · cites it directly · 116 of its ownK113647 DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2011
- Descendant · 2 generations on · 107 of its ownK121010 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- Descendant · 2 generations on · 103 of its ownK120699 DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- Descendant · cites it directly · 101 of its ownK132228 Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- Descendant · 2 generations on · 99 of its ownK142466 UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
Showing 5 of 339 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 339 · See all- K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2011 · cites it directly116descendants
- K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012 · 2 generations on107descendants
- K120699DC-T6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012 · 2 generations on103descendants
- K132228Ugeo PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013 · cites it directly101descendants
- K142466UGEO PT60A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014 · 2 generations on99descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961459 | Level 10 Hdi | Advanced Technology Laboratories, Inc. | 1997 | — |
| −1 | K014116 | Hand-Carried Ultrasound System | Sonosite,Inc. | 2001 | — |
| 0 (this device) | K101757 | Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound… | Sonosite,Inc. | 2010 | — |
| +1 | K113647 | DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2011 | — |
| +2 | K121010 | M7/M7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| +2 | K120699 | DC-T6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| +1 | K132228 | Ugeo PT60A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| +2 | K142466 | UGEO PT60A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 8 | 0 |
| 2013 | 12 | 0 |
| 2014 | 12 | 0 |
| 2015 | 18 | 0 |
| 2016 | 25 | 0 |
| 2017 | 32 | 0 |
| 2018 | 26 | 0 |
| 2019 | 27 | 0 |
| 2020 | 28 | 0 |
| 2021 | 29 | 0 |
| 2022 | 27 | 0 |
| 2023 | 21 | 0 |
| 2024 | 28 | 0 |
| 2025 | 28 | 0 |
| 2026 | 17 | 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K014116 | Hand-Carried Ultrasound SystemSummary page 2…s used to acquire and display high resolution, real-time ultrasound data in a variety of modes and clinical settings. The SonoSite 18OTMA Hand Carried Ultrasound System (K0141 16) provided clearance for a fully described cardiac indication including the imaging of surrounding structures, notably the Lung. T… | 2001 |
What descends from it? (339)
See all 3395 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113647 | DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound System | 2011 | 116 |
| K132228 | Ugeo PT60A Diagnostic Ultrasound System | 2013 | 101 |
| K121699 | Acuson X300 Diagnostic Ultrasound System Sonovista X300 Diagnostic Ultrasound System | 2012 | 98 |
| K130173 | Sonosite Maxx Series Ultrasound System | 2013 | 52 |
| K121646 | Acuson X150 Diagnostic Ultrasound System Sonovista X150 Diagnostic Ultrasound System | 2012 | 0 |
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 13 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K113647 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2011) has gone furthest, with 116 descendants of its own.
- 5 other devices also cite its predicate K014116.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The SonoSite Series Ultrasound Systems are a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Ophthalmic, Fetal/OB; Abdominal; Intra-operative (abdominal organs and vascular); Laparoscopic; Pediatric; Small Organ (breast, thyroid, testicles, prostate); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Trans-esophageal (cardiac); Peripheral Vessel.
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/K101757 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101757: Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101757
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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