510(k) · Cleared
ClearedM5 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Oct 22, 2010 as substantially equivalent to K100830 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2010) and 2 other predicates after a 15-day review. Its family tree reaches back 17 generations to 1995. 128 later devices descend from it.
- Decided
- Oct 22, 2010
- Review
- 15 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K935595 (1995). 117 ancestors in all, the oldest K852159 (1985). 128 later devices descend from it, 8 citing it directly.
- Root · 17 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 13 generations between
- 3 generations backK091941 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 2 generations backK092691 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 1 generation backK100830 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- This deviceK102991 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- Descendant · cites it directly · 109 of its ownK122010 Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- Descendant · 2 generations on · 97 of its ownK123185 DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012
- Descendant · 3 generations on · 96 of its ownK132341 DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2013
- Descendant · 4 generations on · 83 of its ownK141010 M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2014
- Descendant · 4 generations on · 79 of its ownK150080 DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
Show all 17 generations
- Root · 17 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 16 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 15 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 14 generations backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 13 generations backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- 12 generations backK043078 Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C · 2004 · Recalled
- 11 generations backK051500 Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C · 2005
- 10 generations backK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- 9 generations backK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 8 generations backK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- 7 generations backK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- 6 generations backK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 5 generations backK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 4 generations backK083505 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- 3 generations backK091941 DC-3/DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 2 generations backK092691 DC-7 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2009
- 1 generation backK100830 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
- This deviceK102991 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2010
Showing 5 of 128 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 128 · See all- K122010Z6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012 · cites it directly109descendants
- K123185DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012 · 2 generations on97descendants
- K132341DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound SystemsShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2013 · 3 generations on96descendants
- K141010M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2014 · 4 generations on83descendants
- K150080DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8SShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 4 generations on79descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −16 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −15 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −14 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| −13 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −12 | K043078 | Nemio Diagnostic Ultrasound System, Model Ssa-550A | Toshiba America Medical Systems, In.C | 2004 | 1 |
| −11 | K051500 | Famio Diagnostic Ultrasound Systems, Model Ssa-530A | Toshiba America Medical Systems, In.C | 2005 | — |
| −10 | K053346 | Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| −9 | K061189 | DP-9900 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −8 | K063500 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| −7 | K072164 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| −6 | K080640 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −5 | K081320 | DC-3, DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −4 | K083505 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| −3 | K091941 | DC-3/DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −2 | K092691 | DC-7 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2009 | — |
| −1 | K100830 | M7/M7T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| 0 (this device) | K102991 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2010 | — |
| +1 | K122010 | Z6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| +2 | K123185 | DC-8/DC-8 Pro/DC-8, CV/DC-8, Exp/DC-8S Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2012 | — |
| +3 | K132341 | DC-8/ DC-8 Pro/ DC-8 CV/ DC-8 Exp/ DC-8S Diagnostic Ultrasound Systems | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2013 | — |
| +4 | K141010 | M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2014 | — |
| +4 | K150080 | DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 8 | 0 |
| 2000 | 7 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 9 | 0 |
| 2004 | 13 | 0 |
| 2005 | 9 | 0 |
| 2006 | 8 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 2 | 0 |
| 2015 | 10 | 0 |
| 2016 | 7 | 0 |
| 2017 | 14 | 0 |
| 2018 | 10 | 0 |
| 2019 | 10 | 0 |
| 2020 | 10 | 0 |
| 2021 | 10 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 12 | 0 |
| 2025 | 11 | 0 |
| 2026 | 4 | 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? (3)
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 |
|---|---|---|---|
| * | K100830 | M7/M7T Diagnostic Ultrasound SystemSummary page 1…ound Transducer (90-ITX) 3. Marketed Device: The subject device is substantially equivalent in its technologies and functionality to the following devices: Mindray M17(K100830), Mindray M5(K083001) and Mindray DC-6(K072 164). 4. Device Description: B- I ===… | 2010 |
| * | K083001 | M5 Diagnostic Ultrasound SystemSummary page 1…TX) 3. Marketed Device: The subject device is substantially equivalent in its technologies and functionality to the following devices: Mindray M17(K100830), Mindray M5(K083001) and Mindray DC-6(K072 164). 4. Device Description: B- I The M5 Di… | 2008 |
| * | K072164 | DC-6 Diagnostic Ultrasound SystemSummary page 1…The subject device is substantially equivalent in its technologies and functionality to the following devices: Mindray M17(K100830), Mindray M5(K083001) and Mindray DC-6(K072 164). 4. Device Description: B- I The M5 Diagnostic Ultrasound System… | 2007 |
What descends from it? (128)
See all 1288 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122010 | Z6 Diagnostic Ultrasound System | 2012 | 109 |
| K113153 | DP-20 and DP-30 Digital Ultrasonic Diagnostic Imaging System | 2011 | 76 |
| K130695 | Z5 Diagnostic Ultrasound System | 2013 | 74 |
| K123249 | Diagnostic Ultrasound System | 2013 | 21 |
| K111435 | DP-50 Digital Ultrasonic Diagnostic Imaging System | 2011 | 2 |
| K131830 | Digital Ultrasonic Diagnostic Imaging System | 2013 | 1 |
| K113632 | DP-5 Digital Ultrasonic Diagnostic Imaging System DP-7 Digital Ultrasonic Diagnostic… | 2012 | 0 |
| K102865 | DC-7 Diagnostic Ultrasound System, DC-3/DC-3T Diagnostic Ultrasound System | 2010 | 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 15 years and passes through 4 companies; a new generation was cleared every 7 months on median.
- 26 of the 117 ancestors have a recall of any class.
- Of its descendants, K122010 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2012) has gone furthest, with 109 descendants of its own.
- 2 other devices also cite its predicate K100830.
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. 2010, 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?
The M5 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdomen, gynecology, obstetrics, small parts (breast, testes, thyroid, etc.), pediatrics, transcranial, cardiac, peripheral vascular, urology, orthopedics, intraoperative and musculoskeletal (general and superficial) exams.
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/K102991 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102991: M5 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102991
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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