510(k) · Cleared
Clearedbk2300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bk Medical Aps · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Oct 17, 2016 as substantially equivalent to K151910 (Bk Medical Aps, 2015) and 3 other predicates after a 91-day review. Its family tree reaches back 14 generations to 1989. 5 later devices descend from it.
- Decided
- Oct 17, 2016
- Review
- 91 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K894632 (1989). 133 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 10 generations between
- 3 generations backK091295 Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C · 2009 · Recalled
- 2 generations backK092179 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version…Toshiba America Medical Systems, In.C · 2009 · Recalled
- 1 generation backK103629 Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C · 2011
- This deviceK161960 bk2300Bk Medical Aps · 2016
- Descendant · cites it directly · 2 of its ownK180737 Ultrasound Scanner System bk2300Bk Medical Aps · 2018
- Descendant · 2 generations on · 1 of its ownK222441 Ultrasound System 2300Bk Medical Aps · 2022
- Descendant · cites it directly · 1 of its ownK173569 Ultrasound System 1300Bk Medical Aps · 2018
- Descendant · 2 generations on · 0 of its ownK231764 Ultrasound System 1300Bk Medical Aps · 2023 · Recalled
- Descendant · 3 generations on · 0 of its ownK223830 Ultrasound System 2300Bk Medical Aps · 2023 · Recalled
Show all 14 generations
- Root · 14 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 13 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 12 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 11 generations backK991858 Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C · 1999
- 10 generations backK013633 Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001
- 9 generations backK022400 Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · Recalled
- 8 generations backK032281 Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003
- 7 generations backK063130 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation · 2006 · Recalled
- 6 generations backK072000 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C · 2007
- 5 generations backK081065 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2Toshiba America Medical Systems, In.C · 2008
- 4 generations backK082119 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C · 2008
- 3 generations backK091295 Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C · 2009 · Recalled
- 2 generations backK092179 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version…Toshiba America Medical Systems, In.C · 2009 · Recalled
- 1 generation backK103629 Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C · 2011
- This deviceK161960 bk2300Bk Medical Aps · 2016
Most influential descendants
Showing 5 of 5 · See all- K180737Ultrasound Scanner System bk2300Bk Medical Aps · 2018 · cites it directly2descendants
- K222441Ultrasound System 2300Bk Medical Aps · 2022 · 2 generations on1descendant
- K173569Ultrasound System 1300Bk Medical Aps · 2018 · cites it directly1descendant
- K231764Ultrasound System 1300Bk Medical Aps · 2023 · 2 generations on0descendants
- K223830Ultrasound System 2300Bk Medical Aps · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −13 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −12 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −11 | K991858 | Ssa-390A/Power Vision 8000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −10 | K013633 | Ssa-770A, Aplio Ultrasound System | Toshiba America Medical Systems, In.C | 2001 | — |
| −9 | K022400 | Ssa-700A, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2002 | 1 |
| −8 | K032281 | Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2003 | — |
| −7 | K063130 | Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0 | Toshibamedical Systems Corporation | 2006 | 1 |
| −6 | K072000 | Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0 | Toshiba America Medical Systems, In.C | 2007 | — |
| −5 | K081065 | Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2 | Toshiba America Medical Systems, In.C | 2008 | — |
| −4 | K082119 | Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0 | Toshiba America Medical Systems, In.C | 2008 | — |
| −3 | K091295 | Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0 | Toshiba America Medical Systems, In.C | 2009 | 2 |
| −2 | K092179 | Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001 | Toshiba America Medical Systems, In.C | 2009 | 1 |
| −1 | K103629 | Pet-512MC Transesophageal Transducer | Toshiba America Medical Systems, In.C | 2011 | — |
| 0 (this device) | K161960 | bk2300 | Bk Medical Aps | 2016 | — |
| +1 | K180737 | Ultrasound Scanner System bk2300 | Bk Medical Aps | 2018 | — |
| +2 | K222441 | Ultrasound System 2300 | Bk Medical Aps | 2022 | — |
| +1 | K173569 | Ultrasound System 1300 | Bk Medical Aps | 2018 | — |
| +2 | K231764 | Ultrasound System 1300 | Bk Medical Aps | 2023 | 1 |
| +3 | K223830 | Ultrasound System 2300 | Bk Medical Aps | 2023 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 8 | 0 |
| 1996 | 2 | 0 |
| 1997 | 8 | 0 |
| 1998 | 3 | 0 |
| 1999 | 10 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 14 | 0 |
| 2005 | 11 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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.
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? (4)
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 |
|---|---|---|---|
| * | K151910 | Ultrasound Scanner System BK2300Summary page 28…tions meets design specifications. The Ultrasound Scanner System bk2300 with modifications has been compared to the legally marketed predicate devices as cleared through K151910 (October 5, 2015), K132346 (January 10, 2014), K140729 (5/23/2014), and K103629 (2/2/2011) respectively and is found to be substa… | 2015 |
| * | K132346 | Ultrasound Scanner Pro Focus 2202Summary page 28…ations. The Ultrasound Scanner System bk2300 with modifications has been compared to the legally marketed predicate devices as cleared through K151910 (October 5, 2015), K132346 (January 10, 2014), K140729 (5/23/2014), and K103629 (2/2/2011) respectively and is found to be substantially equivalent. This p… | 2014 |
| * | K140729 | Aplio Artida, V3.2Summary page 28…er System bk2300 with modifications has been compared to the legally marketed predicate devices as cleared through K151910 (October 5, 2015), K132346 (January 10, 2014), K140729 (5/23/2014), and K103629 (2/2/2011) respectively and is found to be substantially equivalent. This proposed device is identical… | 2014 |
| * | K103629 | Pet-512MC Transesophageal TransducerSummary page 28…ifications has been compared to the legally marketed predicate devices as cleared through K151910 (October 5, 2015), K132346 (January 10, 2014), K140729 (5/23/2014), and K103629 (2/2/2011) respectively and is found to be substantially equivalent. This proposed device is identical to the identified predica… | 2011 |
| † | K140428 | Ultrasound Scanner System BK2300 | 2014 |
| † | K143298 | Ultrasound Scanner System bk2300 | 2015 |
What descends from it? (5)
2 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 27 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 34 of the 133 ancestors have a recall of any class.
- Of its descendants, K180737 (Bk Medical Aps, 2018) has gone furthest, with 2 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. 2016, 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 system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance. The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (also known as Adult Trans cranial), Neonatal Cephalic, Intra-operative, Intra-operative (Neuro), Trans…
Read the full statement (118 words)
The system is a diagnostic ultrasound imaging system used by qualified and trained healthcare professionals for ultrasound imaging, human body fluid flow analysis and puncture and biopsy guidance.
The clinical applications and exam types include: Fetal (including Obstetrics), Abdominal, Pediatric, Small Organ (also known as Small Parts), Adult Cephalic (also known as Adult Trans cranial), Neonatal Cephalic, Intra-operative, Intra-operative (Neuro), Trans rectal, Trans-vaginal, Trans-urethral, Musculo-skeletal (Conventional and Superficial), Cardiac Adult, Trans-esophageal Cardiology, and Peripheral Vessel (also known as Peripheral Vascular).
Contraindications:
* The 2300 Ultrasound System is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.
* The Cardiac Adult application is not intended for direct use on the heart.
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/K161960 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161960: bk2300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161960
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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