510(k) · Cleared
Recalled · 2008Mycolor 202 Diagnostic Ultrasound System and Transducers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medison America, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on May 30, 2003 as substantially equivalent to K002185 (Medison America, Inc., 2000) and 1 other predicate after an 11-day review. Its family tree reaches back 5 generations to 1993. 184 later devices descend from it. It has been recalled 5 times.
- Decided
- May 30, 2003
- Review
- 11 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 5 generations to K924432 (1993). 12 ancestors in all. 184 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 4 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 3 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 2 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 1 generation backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- This deviceK031552 Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003
- Descendant · cites it directly · 182 of its ownK043455 SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd. · 2004
- Descendant · 2 generations on · 114 of its ownK061213 Sonoace Pico Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- Descendant · 3 generations on · 111 of its ownK100186 Mysono U5 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- Descendant · 4 generations on · 110 of its ownK102065 Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- Descendant · 5 generations on · 108 of its ownK112646 Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
Showing 5 of 184 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 184 · See all- K043455SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd. · 2004 · cites it directly182descendants
- K061213Sonoace Pico Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006 · 2 generations on114descendants
- K100186Mysono U5 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010 · 3 generations on111descendants
- K102065Sonoace R7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010 · 4 generations on110descendants
- K112646Sonoace R7 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011 · 5 generations on108descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −4 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −3 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −2 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −1 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| 0 (this device) | K031552 | Mycolor 202 Diagnostic Ultrasound System and Transducers | Medison America, Inc. | 2003 | — |
| +1 | K043455 | SA8000 SE Diagnostic Ultrasound System | Medison Co., Ltd. | 2004 | — |
| +2 | K061213 | Sonoace Pico Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| +3 | K100186 | Mysono U5 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| +4 | K102065 | Sonoace R7 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| +5 | K112646 | Sonoace R7 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 7 | 0 |
| 2015 | 4 | 0 |
| 2016 | 11 | 0 |
| 2017 | 15 | 0 |
| 2018 | 17 | 0 |
| 2019 | 17 | 0 |
| 2020 | 11 | 0 |
| 2021 | 13 | 0 |
| 2022 | 14 | 0 |
| 2023 | 10 | 0 |
| 2024 | 9 | 0 |
| 2025 | 13 | 0 |
| 2026 | 8 | 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? (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 |
|---|---|---|---|
| * | K002185 | Sonoace SA 9900 Diagnostic Ultrasound SystemSummary page 9…agnostic ultrasound imaging or fluid flow analysis of the human body as follows : N= new indication; P= previously cleared by FDA in KO13627 and K002185; P1= previously clerued by FDA i11 K013627; P2= previously clerued by FDA in K002185; E= added urider Appendix E… | 2000 |
| * | K013627 | Sonoace SA-8000 Diagnostic Ultrasound SystemSummary page 9…nalysis of the human body as follows : N= new indication; P= previously cleared by FDA in KO13627 and K002185; P1= previously clerued by FDA i11 K013627; P2= previously clerued by FDA in K002185; E= added urider Appendix E Additional Comments: Color… | 2001 |
What descends from it? (184)
See all 1842 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 12, 2008 | Not classified | Z-0523-2009 | Software design | The system has a software defect that affects the display of Estimated Fetal Weight (EFW) Growth Percentile result values. |
| Aug 12, 2008 | Not classified | Z-0522-2009 | Software design | The system has a software defect that affects the display of Estimated Fetal Weight (EFW) Growth Percentile result values. |
| May 29, 2008 | Not classified | Z-2013-2008 | Labeling design | HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use. |
| May 29, 2008 | Not classified | Z-2015-2008 | Labeling design | HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use. |
| May 29, 2008 | Not classified | Z-2014-2008 | Labeling design | HD3 Biopsy Guide Kits do not contain adequate labeling instructions for safe and effective use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K043455 (Medison Co., Ltd., 2004) has gone furthest, with 182 descendants of its own.
- 4 other devices also cite its predicate K002185.
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?
mycolor 202 intended uses as defined FDA guidance documents are:
Fetal (includes infertility monitoring of follicle development)
Abdominal
Pediatric
Small Organ
Cardiac (Adult)
Trans-Rectal
Trans-Vaginal
Peripheral-Vascular
Muscular-Skeletal (conventional, superficial)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031552: Mycolor 202 Diagnostic Ultrasound System and Transducers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031552
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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