510(k) Report

510(k) · Cleared

Cleared

Ultrasound Scanner, Type 2102

K011417510(k) TraditionalCleared Jun 8, 200130-day reviewClass II21 CFR 892.1560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

B-K Medical A/S · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Jun 8, 2001 after a 30-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
Jun 8, 2001
Review
30 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
0

92 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2005: 2 descendants cleared2010: 1 descendant cleared2008: 1 descendant cleared2011: 1 descendant cleared2014: 3 descendants cleared2015: 4 descendants cleared2016: 7 descendants cleared2013: 1 descendant cleared2025: 11 descendants cleared2018: 6 descendants cleared2023: 7 descendants cleared2019: 8 descendants cleared2022: 8 descendants cleared2017: 5 descendants cleared2020: 4 descendants cleared2021: 9 descendants cleared2026: 3 descendants cleared2024: 10 descendants cleared200020052010201520202025
  1. This deviceK011417 Ultrasound Scanner, Type 2102B-K Medical A/S · 2001
  2. Descendant · cites it directly · 91 of its ownK024236 Ultrasound Scanner, Type 2400B-K Medical A/S · 2003 · Recalled
  3. Descendant · 2 generations on · 88 of its ownK043524 Ultrasound Scanner Pro Focus, Model 2202B-K Medical A/S · 2005 · Recalled
  4. Descendant · 3 generations on · 82 of its ownK100919 Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202B-K Medical Aps · 2011
  5. Descendant · 3 generations on · 76 of its ownK081154 Ultrasound Scanner Flex Focus, Model 1202B-K Medical Aps · 2008
  6. 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

2003: 12005: 22008: 12010: 12011: 12013: 12014: 32015: 42016: 72017: 52018: 62019: 82020: 42021: 92022: 82023: 72024: 102025: 112026: 3
2003high 11 (2025) · low 0 (2004)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011417Ultrasound Scanner, Type 2102B-K Medical A/S2001—
+1K024236Ultrasound Scanner, Type 2400B-K Medical A/S20032
+2K043524Ultrasound Scanner Pro Focus, Model 2202B-K Medical A/S20051
+3K100919Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202B-K Medical Aps2011—
+3K081154Ultrasound Scanner Flex Focus, Model 1202B-K Medical Aps2008—
+4K123254Ultrasound Scanner Flex FocusB-K Medical Aps2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200520
200810
201010
201110
201310
201430
201540
201670
201750
201860
201980
202040
202190
202280
202370
2024100
2025110
202630
FIG. 1 — Lineage of K011417, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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 92

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K024236Ultrasound Scanner, Type 2400B-K Medical A/S200391

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 IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYO

7in 2025

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

More from B-K Medical A/S

7 FDA decisions under this applicant name. See the company

  • K043554Ultrasound Scanner Mini Focus, Model 1402B-K Medical A/S · 2005
  • K043524Ultrasound Scanner Pro Focus, Model 2202B-K Medical A/S · 20051 recall
  • K024236Ultrasound Scanner, Type 2400B-K Medical A/S · 20032 recalls
  • K023457Ultrasound Scanner, Type 1101B-K Medical A/S · 2002
  • K003986Ultrasound Scanner Type 2102B-K Medical A/S · 2001

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https://510kreport.com/device/K011417 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011417: Ultrasound Scanner, Type 2102.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011417

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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