510(k) · Cleared
ClearedHS50 Diagnostic Ultrasound System, HS60 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 9, 2021 as substantially equivalent to K192505 (Samsung Medison Co., Ltd., 2019) and 1 other predicate after an 88-day review. Its family tree reaches back 31 generations to 1993.
- Decided
- Apr 9, 2021
- Review
- 88 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 31 generations to K924432 (1993). 306 ancestors in all, the oldest K863700 (1987). No later device cites it as a predicate yet.
- 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 backK192505 HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd. · 2019
- This deviceK210068 HS50 Diagnostic Ultrasound System, HS60 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 backK192505 HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd. · 2019
- This deviceK210068 HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2021
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 | K192505 | HS50/HS60 Diagnostics Ultrasound System | Samsung Medison Co., Ltd. | 2019 | — |
| 0 (this device) | K210068 | HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 10 | 0 |
| 1998 | 4 | 0 |
| 1999 | 10 | 0 |
| 2000 | 9 | 0 |
| 2001 | 15 | 0 |
| 2002 | 14 | 0 |
| 2003 | 23 | 0 |
| 2004 | 23 | 0 |
| 2005 | 15 | 0 |
| 2006 | 13 | 0 |
| 2007 | 10 | 0 |
| 2008 | 9 | 0 |
| 2009 | 8 | 0 |
| 2010 | 16 | 0 |
| 2011 | 15 | 0 |
| 2012 | 14 | 0 |
| 2013 | 14 | 0 |
| 2014 | 10 | 0 |
| 2015 | 8 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 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 |
|---|---|---|---|
| * | K192505 | HS50/HS60 Diagnostics Ultrasound SystemSummary page 4…IYN, IYO, ITX Regulation Number : 21 CFR 892.1550, 892.1560, 892.1570 6. Predicate Devices - HS50 / HS60 Diagnostic Ultrasound System (K192505) - Primary - HERA W9/ HERA W10 Diagnostic Ultrasound System (Kl92319) 7. Device Description The HS50… | 2019 |
| * | K192319 | HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound SystemSummary page 5…e proposed HS50/ HS60 migrated new SW features MV-FlowTM, LumiFlowTM, S-DetectTM for Thyroid, Slab 3D from predicates HERA W9/HERA W10 (K192319). - MV-FlowTM visualizes microcirculatory and slow blood flow to display the intensity of blood f… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- 77 of the 306 ancestors have a recall of any class.
- 1 other device also cites its predicate K192505.
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. 2021, 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 HS50 / HS60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. 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, Trans-esophageal(Cardiac) and peripheral vessel. It is…
Read the full statement (139 words)
The HS50 / HS60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
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, Trans-esophageal(Cardiac) and peripheral vessel.
It 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. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.
Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210068: HS50 Diagnostic Ultrasound System, HS60 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/K210068
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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