510(k) · Cleared
Recalled · 2008Ultrasound Scanner Pro Focus, Model 2202
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B-K Medical A/S · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jan 13, 2005 as substantially equivalent to K024236 (B-K Medical A/S, 2003) after a 24-day review. Its family tree reaches back 2 generations to 2000. 88 later devices descend from it. It has been recalled once.
- Decided
- Jan 13, 2005
- Review
- 24 days
- Class
- Class II
- Product code
- IYN
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000567 (2000). 4 ancestors in all. 88 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK000567 Ultrasound Scanner Type 2102B & K Medical A/S · 2000 · Recalled
- 1 generation backK024236 Ultrasound Scanner, Type 2400B-K Medical A/S · 2003 · Recalled
- This deviceK043524 Ultrasound Scanner Pro Focus, Model 2202B-K Medical A/S · 2005
- Descendant · cites it directly · 82 of its ownK100919 Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202B-K Medical Aps · 2011
- Descendant · cites it directly · 76 of its ownK081154 Ultrasound Scanner Flex Focus, Model 1202B-K Medical Aps · 2008
- Descendant · 2 generations on · 68 of its ownK123254 Ultrasound Scanner Flex FocusB-K Medical Aps · 2013
- Descendant · 2 generations on · 66 of its ownK132335 Ultrasound Scanner Flex Focus 1202B-K Medical Aps · 2014 · Recalled
- Descendant · 3 generations on · 65 of its ownK152763 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
Showing 5 of 88 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 88 · See all- K100919Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202B-K Medical Aps · 2011 · cites it directly82descendants
- K081154Ultrasound Scanner Flex Focus, Model 1202B-K Medical Aps · 2008 · cites it directly76descendants
- K123254Ultrasound Scanner Flex FocusB-K Medical Aps · 2013 · 2 generations on68descendants
- K132335Ultrasound Scanner Flex Focus 1202B-K Medical Aps · 2014 · 2 generations on66descendants
- K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 3 generations on65descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000567 | Ultrasound Scanner Type 2102 | B & K Medical A/S | 2000 | 1 |
| −1 | K024236 | Ultrasound Scanner, Type 2400 | B-K Medical A/S | 2003 | 2 |
| 0 (this device) | K043524 | Ultrasound Scanner Pro Focus, Model 2202 | B-K Medical A/S | 2005 | — |
| +1 | K100919 | Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202 | B-K Medical Aps | 2011 | — |
| +1 | K081154 | Ultrasound Scanner Flex Focus, Model 1202 | B-K Medical Aps | 2008 | — |
| +2 | K123254 | Ultrasound Scanner Flex Focus | B-K Medical Aps | 2013 | — |
| +2 | K132335 | Ultrasound Scanner Flex Focus 1202 | B-K Medical Aps | 2014 | 1 |
| +3 | K152763 | Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound… | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 7 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 8 | 0 |
| 2020 | 4 | 0 |
| 2021 | 9 | 0 |
| 2022 | 8 | 0 |
| 2023 | 7 | 0 |
| 2024 | 10 | 0 |
| 2025 | 11 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K024236 | Ultrasound Scanner, Type 2400Summary page 1…2.1560) Diagnostic Ultrasonic Transducer (90 ITX, CFR 892.1570) Identification of predicate, legally marketed device: B-K Medical Ultrasound Scanner Type 2400, K024236 (JAN17 2003) Device description: Pro Focus 2202 supports the following scanning modes and combinations thereof: B-mode, M-mode,… | 2003 |
What descends from it? (88)
See all 885 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 |
|---|---|---|---|---|
| Jan 24, 2008 | Not classified | Z-1140-2008 | Process control | Crack: Incomplete glue joint in the device housing may affect electrical safety or sterilization. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K100919 (B-K Medical Aps, 2011) has gone furthest, with 82 descendants of its own.
- 2 other devices also cite its predicate K024236.
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.
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:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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/K043524 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043524: Ultrasound Scanner Pro Focus, Model 2202.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043524
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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