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 Sep 16, 2015 after a 55-day review. The FDA summary names no predicate by number. It has been recalled once.
- Decided
- Sep 16, 2015
- Review
- 55 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
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.
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?
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography. Signal Analysis. Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping…
Read the full statement (162 words)
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging and Elastography.
Signal Analysis.
Guidance of biopsy needles, geometrical measurements and calculation of parameters. And optimal 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.
An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
Clinical Applications:
• Fetal (Sometimes called Obstetrics)
• Abdominal
• Intra-operative
• Intra-operative (Neuro) (sometimes called Neuro Surgical)
• Pediatrics
• Small Organ (Sometimes called Small Parts)
• Neonatal Cephalic (Cephalic is sometimes called trans-cranial)
• Adult Cephalic (Cephalic is sometimes called trans-cranial)
• Trans-rectal
• Trans-vaginal
• Trans-urethral
• Musculo-skeletal (Conventional)
• Musculo-skeletal (Superficial)
• Cardiac Adult
• Peripheral Vessel (Sometimes called Peripheral Vascular)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152052: 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/K152052
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026