510(k) · Cleared
ClearedUltrasound Scanner 2002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B&K Medical · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Feb 9, 1996 after a 578-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 9, 1996
- Review
- 578 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK943315 Ultrasound Scanner 2002B&K Medical · 1996
- Descendant · cites it directly · 1 of its ownK992152 General Purpose Transducer Standoff, Biopsy Transducer Standoff…CIVCO Medical Instruments Co., Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK080119 ClearscanEsi, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK991937 Ultrasound Scanner, Model Type 2101B & K Medical A/S · 1999 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K992152General Purpose Transducer Standoff, Biopsy Transducer Standoff, BI-Plane Endocavity…CIVCO Medical Instruments Co., Inc. · 1999 · cites it directly1descendant
- K080119ClearscanEsi, Inc. · 2008 · 2 generations on0descendants
- K991937Ultrasound Scanner, Model Type 2101B & K Medical A/S · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943315 | Ultrasound Scanner 2002 | B&K Medical | 1996 | — |
| +1 | K992152 | General Purpose Transducer Standoff, Biopsy Transducer Standoff, BI-Plane… | CIVCO Medical Instruments Co., Inc. | 1999 | — |
| +2 | K080119 | Clearscan | Esi, Inc. | 2008 | — |
| +1 | K991937 | Ultrasound Scanner, Model Type 2101 | B & K Medical A/S | 1999 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2008 | 1 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K992152 (CIVCO Medical Instruments Co., Inc., 1999) has gone furthest, with 1 descendant 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.
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/K943315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943315: Ultrasound Scanner 2002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943315
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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