510(k) · Cleared
ClearedUltrasound Scanner Type 2102
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 Apr 3, 2001 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 92 later devices descend from it.
- Decided
- Apr 3, 2001
- Review
- 98 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 0
92 later devices descend from it, 1 citing it directly.
- This deviceK003986 Ultrasound Scanner Type 2102B-K Medical A/S · 2001
- Descendant · cites it directly · 91 of its ownK024236 Ultrasound Scanner, Type 2400B-K Medical A/S · 2003 · Recalled
- Descendant · 2 generations on · 88 of its ownK043524 Ultrasound Scanner Pro Focus, Model 2202B-K Medical A/S · 2005 · Recalled
- Descendant · 3 generations on · 82 of its ownK100919 Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202B-K Medical Aps · 2011
- Descendant · 3 generations on · 76 of its ownK081154 Ultrasound Scanner Flex Focus, Model 1202B-K Medical Aps · 2008
- Descendant · 4 generations on · 68 of its ownK123254 Ultrasound Scanner Flex FocusB-K Medical Aps · 2013
Showing 5 of 92 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 92 · See all- K024236Ultrasound Scanner, Type 2400B-K Medical A/S · 2003 · cites it directly91descendants
- K043524Ultrasound Scanner Pro Focus, Model 2202B-K Medical A/S · 2005 · 2 generations on88descendants
- K100919Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202B-K Medical Aps · 2011 · 3 generations on82descendants
- K081154Ultrasound Scanner Flex Focus, Model 1202B-K Medical Aps · 2008 · 3 generations on76descendants
- K123254Ultrasound Scanner Flex FocusB-K Medical Aps · 2013 · 4 generations on68descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003986 | Ultrasound Scanner Type 2102 | B-K Medical A/S | 2001 | — |
| +1 | 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 |
| +3 | K100919 | Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202 | B-K Medical Aps | 2011 | — |
| +3 | K081154 | Ultrasound Scanner Flex Focus, Model 1202 | B-K Medical Aps | 2008 | — |
| +4 | K123254 | Ultrasound Scanner Flex Focus | B-K Medical Aps | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (92)
See all 921 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024236 | Ultrasound Scanner, Type 2400 | 2003 | 91 |
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, K024236 (B-K Medical A/S, 2003) has gone furthest, with 91 descendants of its own.
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) | — |
https://510kreport.com/device/K003986 · printed Nov 5, 2026
Cite this page
510(k) Report. “K003986: Ultrasound Scanner Type 2102.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003986
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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