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 Aug 22, 2022 as substantially equivalent to K210426 (Samsung Medison Co., Ltd., 2021) after an 81-day review. Its family tree reaches back 33 generations to 1993. 6 of the 374 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 22, 2022
- Review
- 81 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 33 generations to K924432 (1993). 373 ancestors in all, the oldest K844472 (1985). No later device cites it as a predicate yet. 6 of the 374 devices in this family, counting this one, have a Class I recall.
- Root · 33 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 29 generations between
- 3 generations backK191055 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2019
- 2 generations backK200339 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2020
- 1 generation backK210426 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2021
- This deviceK221599 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2022
Show all 33 generations
- Root · 33 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 32 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 31 generations backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- 30 generations backK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- 29 generations backK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- 28 generations backK032329 SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
- 27 generations backK052911 Accuvix XQ Diagnostic Ultrasound SystemMedison Co., Ltd. · 2005
- 26 generations backK063580 Sonoace X8 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2006
- 25 generations backK070813 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2007
- 24 generations backK080800 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2008
- 23 generations backK092159 Accuvix V20 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2009
- 22 generations backK093849 Accuvix V10 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 21 generations backK101455 Eko 7 Diagnostic Ultrasound SystemMedison Co., Ltd. · 2010
- 20 generations backK103397 Accuvix XG Diagnostic Ultrasound SystemMedison Co., Ltd. · 2011
- 19 generations backK112339 Accuvix A30 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2011
- 18 generations backK122583 Ugeo G60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2012
- 17 generations backK130803 Ugeo H70C Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- 16 generations backK133329 Ugeo WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2013
- 15 generations backK141620 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- 14 generations backK143089 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2014
- 13 generations backK150478 A35 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- 12 generations backK151663 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- 11 generations backK152962 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2015
- 10 generations backK153529 WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · Recalled
- 9 generations backK162094 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016
- 8 generations backK163691 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- 7 generations backK170493 HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- 6 generations backK172129 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- 5 generations backK180409 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
- 4 generations backK181336 HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
- 3 generations backK191055 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2019
- 2 generations backK200339 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2020
- 1 generation backK210426 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2021
- This deviceK221599 HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2022
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −33 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −32 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −31 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| −30 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| −29 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| −28 | K032329 | SA 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | 2003 | — |
| −27 | K052911 | Accuvix XQ Diagnostic Ultrasound System | Medison Co., Ltd. | 2005 | — |
| −26 | K063580 | Sonoace X8 Diagnostic Ultrasound System | Medison Co., Ltd. | 2006 | — |
| −25 | K070813 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2007 | — |
| −24 | K080800 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2008 | — |
| −23 | K092159 | Accuvix V20 Diagnostic Ultrasound System | Medison Co., Ltd. | 2009 | — |
| −22 | K093849 | Accuvix V10 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −21 | K101455 | Eko 7 Diagnostic Ultrasound System | Medison Co., Ltd. | 2010 | — |
| −20 | K103397 | Accuvix XG Diagnostic Ultrasound System | Medison Co., Ltd. | 2011 | — |
| −19 | K112339 | Accuvix A30 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2011 | — |
| −18 | K122583 | Ugeo G60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2012 | — |
| −17 | K130803 | Ugeo H70C Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| −16 | K133329 | Ugeo WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2013 | — |
| −15 | K141620 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| −14 | K143089 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2014 | — |
| −13 | K150478 | A35 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| −12 | K151663 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| −11 | K152962 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2015 | — |
| −10 | K153529 | WS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | 1 |
| −9 | K162094 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | — |
| −8 | K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| −7 | K170493 | HS50 / HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| −6 | K172129 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| −5 | K180409 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018 | — |
| −4 | K181336 | HS50 / HS60 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018 | — |
| −3 | K191055 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2019 | — |
| −2 | K200339 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2020 | — |
| −1 | K210426 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2021 | — |
| 0 (this device) | K221599 | HS40 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2022 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K210426 | HS40 Diagnostic Ultrasound SystemSummary page 4…21 CFR 892.1570 Diagnostic ultrasonic transducer - Product Code(s): IYN, IYO, ITX 6. Predicate Device HS40 Diagnostic Ultrasound System (K210426) – Primary Predicate HM70 EVO Diagnostic Ultrasound System (K220269) – Re… | 2021 |
| † | K220269 | HM70 EVO Diagnostic Ultrasound System | 2022 |
| † | K211945 | V8 Diagnostic Ultrasound System | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 8 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 9 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 9 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 9 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 9 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 9 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 29 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- 98 of the 373 ancestors have a recall of any class; 6 have a Class I recall.
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. 2022, 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. It is intended for use by, or by the order of, and under the…
Read the full statement (135 words)
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.
It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional 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/K221599 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221599: HS40 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/K221599
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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