510(k) · Cleared
Recalled · Class II · 2016Ultrasound Scanner System BK2300
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 5, 2015 as substantially equivalent to K143298 (Bk Medical Aps, 2015) after an 84-day review. Its family tree reaches back 5 generations to 2000. 6 later devices descend from it. It has been recalled once.
- Decided
- Oct 5, 2015
- Review
- 84 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K000567 (2000). 10 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK000567 Ultrasound Scanner Type 2102B & K Medical A/S · 2000 · Recalled
- 4 generations backK024236 Ultrasound Scanner, Type 2400B-K Medical A/S · 2003 · Recalled
- 3 generations backK043524 Ultrasound Scanner Pro Focus, Model 2202B-K Medical A/S · 2005 · Recalled
- 2 generations backK100919 Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202B-K Medical Aps · 2011
- 1 generation backK143298 Ultrasound Scanner System bk2300Bk Medical Aps · 2015 · Recalled
- This deviceK151910 Ultrasound Scanner System BK2300Bk Medical Aps · 2015
- Descendant · cites it directly · 5 of its ownK161960 bk2300Bk Medical Aps · 2016
- Descendant · 2 generations on · 2 of its ownK180737 Ultrasound Scanner System bk2300Bk Medical Aps · 2018
- Descendant · 3 generations on · 1 of its ownK222441 Ultrasound System 2300Bk Medical Aps · 2022
- Descendant · 2 generations on · 1 of its ownK173569 Ultrasound System 1300Bk Medical Aps · 2018
- Descendant · 3 generations on · 0 of its ownK231764 Ultrasound System 1300Bk Medical Aps · 2023 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K161960bk2300Bk Medical Aps · 2016 · cites it directly5descendants
- K180737Ultrasound Scanner System bk2300Bk Medical Aps · 2018 · 2 generations on2descendants
- K222441Ultrasound System 2300Bk Medical Aps · 2022 · 3 generations on1descendant
- K173569Ultrasound System 1300Bk Medical Aps · 2018 · 2 generations on1descendant
- K231764Ultrasound System 1300Bk Medical Aps · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000567 | Ultrasound Scanner Type 2102 | B & K Medical A/S | 2000 | 1 |
| −4 | K024236 | Ultrasound Scanner, Type 2400 | B-K Medical A/S | 2003 | 2 |
| −3 | K043524 | Ultrasound Scanner Pro Focus, Model 2202 | B-K Medical A/S | 2005 | 1 |
| −2 | K100919 | Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202 | B-K Medical Aps | 2011 | — |
| −1 | K143298 | Ultrasound Scanner System bk2300 | Bk Medical Aps | 2015 | 1 |
| 0 (this device) | K151910 | Ultrasound Scanner System BK2300 | Bk Medical Aps | 2015 | — |
| +1 | K161960 | bk2300 | Bk Medical Aps | 2016 | — |
| +2 | K180737 | Ultrasound Scanner System bk2300 | Bk Medical Aps | 2018 | — |
| +3 | K222441 | Ultrasound System 2300 | Bk Medical Aps | 2022 | — |
| +2 | K173569 | Ultrasound System 1300 | Bk Medical Aps | 2018 | — |
| +3 | K231764 | Ultrasound System 1300 | Bk Medical Aps | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K143298 | Ultrasound Scanner System bk2300Summary page 28…92.1550) Diagnostic Ultrasonic Transducer (90 ITX, CFR 892.1570) Identification of predicate, legally marketed device: B-K Medical Ultrasound Scanner bk2300, K143298 Device description: Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler,… | 2015 |
| † | K132346 | Ultrasound Scanner Pro Focus 2202 | 2014 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161960 | bk2300 | 2016 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2016 | Class II | Z-2325-2016 | Software design | In the system (bk3500) software generic volume measurement (HxWxLxl) function the user may be unaware of the calculation factor (1) and assume the generic volume calculation factor is similar to that of the other (prostate, adenoma… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 2.9 years on median.
- 5 of the 10 ancestors have a recall of any class.
- Of its descendants, K161960 (Bk Medical Aps, 2016) has gone furthest, with 5 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. 2015, 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?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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/K151910 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151910: Ultrasound Scanner System BK2300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151910
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