510(k) · Cleared
ClearedUltrasound Scanner Pro Focus 2202
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 Jan 10, 2014 as substantially equivalent to K043524 (B-K Medical A/S, 2005) and 1 other predicate after a 165-day review. Its family tree reaches back 4 generations to 2000. 6 later devices descend from it.
- Decided
- Jan 10, 2014
- Review
- 165 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K000567 (2000). 6 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK000567 Ultrasound Scanner Type 2102B & K Medical A/S · 2000 · Recalled
- 3 generations backK024236 Ultrasound Scanner, Type 2400B-K Medical A/S · 2003 · Recalled
- 2 generations backK043524 Ultrasound Scanner Pro Focus, Model 2202B-K Medical A/S · 2005 · Recalled
- 1 generation backK100919 Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202B-K Medical Aps · 2011
- This deviceK132346 Ultrasound Scanner Pro Focus 2202B-K Medical Aps · 2014
- 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 |
|---|---|---|---|---|---|
| −4 | K000567 | Ultrasound Scanner Type 2102 | B & K Medical A/S | 2000 | 1 |
| −3 | K024236 | Ultrasound Scanner, Type 2400 | B-K Medical A/S | 2003 | 2 |
| −2 | K043524 | Ultrasound Scanner Pro Focus, Model 2202 | B-K Medical A/S | 2005 | 1 |
| −1 | K100919 | Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202 | B-K Medical Aps | 2011 | — |
| 0 (this device) | K132346 | Ultrasound Scanner Pro Focus 2202 | B-K Medical Aps | 2014 | — |
| +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 |
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 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? (2)
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 |
|---|---|---|---|
| * | K043524 | Ultrasound Scanner Pro Focus, Model 2202Summary page 1…) Diagnostic Ultrasonic Transducer (90 ITX CFR 892.1570) Identi fication of predicate, legally marketed device: B-K Medical Ultrasound Scanner Pro Focus 21202, K043524 B-K Medical Ultrasound Scanner Pro Focus 2202, K 100919 Device description: Pro Focus 2202 supports the following scanning mode… | 2005 |
| * | K100919 | Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202Summary page 1…892.1570) Identi fication of predicate, legally marketed device: B-K Medical Ultrasound Scanner Pro Focus 21202, K043524 B-K Medical Ultrasound Scanner Pro Focus 2202, K 100919 Device description: Pro Focus 2202 supports the following scanning modes and combinations thereof. fl-mode (incl.'Iissue Harmon… | 2011 |
| † | K070077 | Ultrasound Scanner Profocus, Model 2202 | 2007 |
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)
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 14 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K161960 (Bk Medical Aps, 2016) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K043524.
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 | — |
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. Signal analysis and display. Guidance of biopsy needles, geometrical measurements and calculation of parameters. Non monitoring ECG for superimposing the ultrasound information. An optionalt3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An…
Read the full statement (120 words)
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD,CWD, Color Doppler, Vector Flow Imaging and combined mode imaging.
Signal analysis and display.
Guidance of biopsy needles, geometrical measurements and calculation of parameters.
Non monitoring ECG for superimposing the ultrasound information.
An optionalt3-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 (VP!) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.
An optional liP wireless function with the ability to wireless transmit for printing and archive connectivity purpose.
Clinical applications: Abdominal, Cardiac, Fetal, lntmaoperative, Neurosurgery, Obstetrics, PediatricsTransrectal, Small organs. Transvaginal. Musculoskeletal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132346: Ultrasound Scanner Pro Focus 2202.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132346
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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