510(k) · Cleared
ClearedUltrasound Scanner Profocus, Model 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 Mar 5, 2007 as substantially equivalent to K032111 (Siemens Medical Solutions USA, Inc., 2003) after a 56-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Mar 5, 2007
- Review
- 56 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K935595 (1995). 16 ancestors in all, the oldest K921148 (1992). No later device cites it as a predicate yet.
- Root · 4 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 3 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 2 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 1 generation backK032111 Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
- This deviceK070077 Ultrasound Scanner Profocus, Model 2202B-K Medical Aps · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −3 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −2 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −1 | K032111 | Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2003 | 1 |
| 0 (this device) | K070077 | Ultrasound Scanner Profocus, Model 2202 | B-K Medical Aps | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 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? (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 |
|---|---|---|---|
| * | K032111 | Acuson CV70 Cardiovascular SystemSummary page 2…e major technological characteristics as the subject device, see comparison below. Comparison with Siemens Medical Solutions USA Inc: Acuson CV70 Cardiovascular system (K0321 11) ProFocus 2202 in this K0321 11 application Intended… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 3 of the 16 ancestors have a recall of any class.
- 3 other devices also cite its predicate K032111.
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. 2007, 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 and combined mode imaging.
Guidance of biopsy needles, geometrical measurements and calculation of
parameters.
Non monitoring ECG for superimposing the ultrasound information.
An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume
and display this on the screen.
Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery,
Obstetrics, Pediatrics, Transcranial (=Adult cephalic),Transrectal, Small organs,
Transvaginal, Musculoskeletal
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070077 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070077: Ultrasound Scanner Profocus, Model 2202.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070077
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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