510(k) · Cleared
ClearedModification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model DP-9900
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 Dec 9, 2005 as substantially equivalent to K043563 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2005) and 1 other predicate after a 7-day review. Its family tree reaches back 7 generations to 1995. 194 later devices descend from it.
- Decided
- Dec 9, 2005
- Review
- 7 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K935595 (1995). 27 ancestors in all, the oldest K852159 (1985). 194 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 6 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 5 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 4 generations backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- 3 generations backK040060 Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
- 2 generations backK043078 Nemio Diagnostic Ultrasound System, Model Ssa-550AToshiba America Medical Systems, In.C · 2004 · Recalled
- 1 generation backK051500 Famio Diagnostic Ultrasound Systems, Model Ssa-530AToshiba America Medical Systems, In.C · 2005
- This deviceK053346 Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2005
- Descendant · cites it directly · 193 of its ownK061189 DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- Descendant · 2 generations on · 189 of its ownK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
- Descendant · 3 generations on · 188 of its ownK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
- Descendant · 4 generations on · 182 of its ownK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · 4 generations on · 180 of its ownK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
Showing 5 of 194 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 194 · See all- K061189DP-9900 Digital Ultrasonic Diagnostic Imaging SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · cites it directly193descendants
- K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · 2 generations on189descendants
- K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · 3 generations on188descendants
- K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 4 generations on182descendants
- K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 4 generations on180descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −6 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −5 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −4 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| −3 | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −2 | K043078 | Nemio Diagnostic Ultrasound System, Model Ssa-550A | Toshiba America Medical Systems, In.C | 2004 | 1 |
| −1 | K051500 | Famio Diagnostic Ultrasound Systems, Model Ssa-530A | Toshiba America Medical Systems, In.C | 2005 | — |
| 0 (this device) | K053346 | Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2005 | — |
| +1 | K061189 | DP-9900 Digital Ultrasonic Diagnostic Imaging System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| +2 | K063500 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006 | — |
| +3 | K072164 | DC-6 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007 | — |
| +4 | K080640 | M5 Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +4 | K081320 | DC-3, DC-3T Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 7 | 0 |
| 2011 | 9 | 0 |
| 2012 | 7 | 0 |
| 2013 | 9 | 0 |
| 2014 | 2 | 0 |
| 2015 | 17 | 0 |
| 2016 | 10 | 0 |
| 2017 | 25 | 0 |
| 2018 | 12 | 0 |
| 2019 | 11 | 0 |
| 2020 | 13 | 0 |
| 2021 | 10 | 0 |
| 2022 | 9 | 0 |
| 2023 | 8 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 0 |
| 2026 | 6 | 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? (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 |
|---|---|---|---|
| * | K043563 | DP-9900 Digital Ultrasonic Diagnostic Imaging SystemSummary page 2…sducer (90-ITX) 0022 Legally Marketed Predicate Device: 1(043563 DPJ-9900 Digital Ultrasonic Diagnostic Imaging Systemn K051500 SSA-530A Famnio Diagnostic Ultrasound System Desc… | 2005 |
| * | K051500 | Famio Diagnostic Ultrasound Systems, Model Ssa-530ASummary page 2…0022 Legally Marketed Predicate Device: 1(043563 DPJ-9900 Digital Ultrasonic Diagnostic Imaging Systemn K051500 SSA-530A Famnio Diagnostic Ultrasound System Description: The DP-9900 Digital Ultrasonic Diagnostic Imaging System with… | 2005 |
What descends from it? (194)
See all 1942 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)
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 10 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 4 of the 27 ancestors have a recall of any class.
- Of its descendants, K061189 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2006) has gone furthest, with 193 descendants of its own.
- 1 other device also cites its predicate K043563.
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.
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?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053346: Modification to: DP-9900 Digital Ultrasonic Diagnostic Imaging System, Model DP-9900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053346
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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