510(k) · Cleared
ClearedHS40 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Samsung Medison Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Apr 7, 2020 as substantially equivalent to K191055 (Samsung Medison Co., Ltd., 2019) and 1 other predicate after a 56-day review. Its family tree reaches back 31 generations to 1993. 6 of the 380 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it.
- Decided
- Apr 7, 2020
- Review
- 56 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 31 generations to K924432 (1993). 371 ancestors in all, the oldest K844472 (1985). 8 later devices descend from it, 3 citing it directly. 6 of the 380 devices in this family, counting this one, have a Class I recall.
- Root · 31 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 27 generations between
- 3 generations backK180409 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
- 2 generations backK181336 HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
- 1 generation backK191055 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2019
- This deviceK200339 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2020
- Descendant · cites it directly · 4 of its ownK210713 HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2021
- Descendant · 2 generations on · 3 of its ownK220269 HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2022
- Descendant · 3 generations on · 2 of its ownK233112 HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2023
- Descendant · 4 generations on · 1 of its ownK254099 EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound…Samsung Medison Co., Ltd. · 2026
- Descendant · cites it directly · 1 of its ownK210426 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2021
Show all 31 generations
- Root · 31 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 30 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 29 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 28 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 27 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 26 generations backK032329 SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
- 25 generations backK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- 24 generations backK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- 23 generations backK070813 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2007
- 22 generations backK080800 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- 21 generations backK092159 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- 20 generations backK093849 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 19 generations backK101455 Eko 7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 18 generations backK103397 Accuvix XG Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011
- 17 generations backK112339 Accuvix A30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- 16 generations backK122583 Ugeo G60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2012
- 15 generations backK130803 Ugeo H70C Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- 14 generations backK133329 Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- 13 generations backK141620 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- 12 generations backK143089 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- 11 generations backK150478 A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- 10 generations backK151663 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- 9 generations backK152962 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- 8 generations backK153529 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · Recalled
- 7 generations backK162094 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016
- 6 generations backK163691 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- 5 generations backK170493 HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- 4 generations backK172129 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- 3 generations backK180409 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
- 2 generations backK181336 HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
- 1 generation backK191055 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2019
- This deviceK200339 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K210713HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2021 · cites it directly4descendants
- K220269HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2022 · 2 generations on3descendants
- K233112HM70 EVO Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2023 · 3 generations on2descendants
- K254099EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10…Samsung Medison Co., Ltd. · 2026 · 4 generations on1descendant
- K210426HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2021 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −31 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −30 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −29 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −28 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −27 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −26 | K032329 | SA 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | 2003 | — |
| −25 | K052911 | Accuvix XQ Diagnostic Ultrasound System | Medison Co., Ltd. | 2005 | — |
| −24 | K063580 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| −23 | K070813 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2007 | — |
| −22 | K080800 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2008 | — |
| −21 | K092159 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
| −20 | K093849 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −19 | K101455 | Eko 7 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −18 | K103397 | Accuvix XG Diagnostic Ultrasound System | Medison Co., Ltd. | 2011 | — |
| −17 | K112339 | Accuvix A30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
| −16 | K122583 | Ugeo G60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2012 | — |
| −15 | K130803 | Ugeo H70C Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| −14 | K133329 | Ugeo WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| −13 | K141620 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| −12 | K143089 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| −11 | K150478 | A35 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| −10 | K151663 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| −9 | K152962 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| −8 | K153529 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | 1 |
| −7 | K162094 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | — |
| −6 | K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| −5 | K170493 | HS50 / HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| −4 | K172129 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| −3 | K180409 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018 | — |
| −2 | K181336 | HS50 / HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018 | — |
| −1 | K191055 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019 | — |
| 0 (this device) | K200339 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020 | — |
| +1 | K210713 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021 | — |
| +2 | K220269 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2022 | — |
| +3 | K233112 | HM70 EVO Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2023 | — |
| +4 | K254099 | EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System… | Samsung Medison Co., Ltd. | 2026 | — |
| +1 | K210426 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 8 | 0 |
| 1995 | 8 | 0 |
| 1996 | 6 | 1 |
| 1997 | 13 | 0 |
| 1998 | 13 | 3 |
| 1999 | 15 | 0 |
| 2000 | 15 | 1 |
| 2001 | 22 | 0 |
| 2002 | 21 | 0 |
| 2003 | 28 | 0 |
| 2004 | 24 | 1 |
| 2005 | 18 | 0 |
| 2006 | 14 | 0 |
| 2007 | 11 | 0 |
| 2008 | 11 | 0 |
| 2009 | 9 | 0 |
| 2010 | 16 | 0 |
| 2011 | 15 | 0 |
| 2012 | 17 | 0 |
| 2013 | 14 | 0 |
| 2014 | 11 | 0 |
| 2015 | 8 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 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.
6 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K191055 | HS40 Diagnostic Ultrasound SystemSummary page 5…P P P P Note 1 Note 2, 5, 7, 9, 11 Vessel Other (spec.) N= new indication; P= previously cleared by FDA K191055 ; E= added under Appendix E Additional Comments: Note 1: B+M, B+PW, B+CW, B+C, B+PD, B+DPD, B+Elastoscan, B+C+PW, B+PD+PW, B+… | 2019 |
| * | K192505 | HS50/HS60 Diagnostics Ultrasound SystemSummary page 23…ageal (Cardiac) Other (spec.) Peripheral Peripheral vessel Vessel Other (spec.) N= new indication; P= previously cleared by FDA K192505 ; E= added under Appendix E Additional Comments: Color Doppler includes Power (Amplitude) Doppler Note 1: B+M, B+PW, B+C… | 2019 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 6 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 7 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 7 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- 98 of the 371 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K210713 (Samsung Medison Co., Ltd., 2021) has gone furthest, with 4 descendants of its own.
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. 2020, this device’s year, is highlighted.
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?
The HS40 diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric and Peripheral vessel.
The HS40 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of medical devices.
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/K200339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200339: HS40 Diagnostic 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/K200339
Report an extraction error
Are you the manufacturer?
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