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
B-K Medical Aps · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 30, 2014 after a 100-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled once.
- Decided
- May 30, 2014
- Review
- 100 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 1
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK140428 Ultrasound Scanner System BK2300B-K Medical Aps · 2014
- Descendant · cites it directly · 7 of its ownK143298 Ultrasound Scanner System bk2300Bk Medical Aps · 2015 · Recalled
- Descendant · 2 generations on · 6 of its ownK151910 Ultrasound Scanner System BK2300Bk Medical Aps · 2015 · Recalled
- Descendant · 3 generations on · 5 of its ownK161960 bk2300Bk Medical Aps · 2016
- Descendant · 4 generations on · 2 of its ownK180737 Ultrasound Scanner System bk2300Bk Medical Aps · 2018
- Descendant · 5 generations on · 1 of its ownK222441 Ultrasound System 2300Bk Medical Aps · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K143298Ultrasound Scanner System bk2300Bk Medical Aps · 2015 · cites it directly7descendants
- K151910Ultrasound Scanner System BK2300Bk Medical Aps · 2015 · 2 generations on6descendants
- K161960bk2300Bk Medical Aps · 2016 · 3 generations on5descendants
- K180737Ultrasound Scanner System bk2300Bk Medical Aps · 2018 · 4 generations on2descendants
- K222441Ultrasound System 2300Bk Medical Aps · 2022 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K140428 | Ultrasound Scanner System BK2300 | B-K Medical Aps | 2014 | — |
| +1 | K143298 | Ultrasound Scanner System bk2300 | Bk Medical Aps | 2015 | 1 |
| +2 | K151910 | Ultrasound Scanner System BK2300 | Bk Medical Aps | 2015 | 1 |
| +3 | K161960 | bk2300 | Bk Medical Aps | 2016 | — |
| +4 | K180737 | Ultrasound Scanner System bk2300 | Bk Medical Aps | 2018 | — |
| +5 | K222441 | Ultrasound System 2300 | Bk Medical Aps | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
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)
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?
- Of its descendants, K143298 (Bk Medical Aps, 2015) has gone furthest, with 7 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
https://510kreport.com/device/K140428 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140428: Ultrasound Scanner System BK2300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140428
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026