510(k) Report

510(k) · Cleared

Cleared

Ultrasound Scanner Flex Focus, Model 1202

K081154510(k) SpecialCleared May 23, 200830-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 Aps · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on May 23, 2008 as substantially equivalent to K043524 (B-K Medical A/S, 2005) after a 30-day review. Its family tree reaches back 3 generations to 2000. 76 later devices descend from it.

Decided
May 23, 2008
Review
30 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K000567 (2000). 5 ancestors in all. 76 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2014: 2 descendants cleared2016: 6 descendants cleared2013: 1 descendant cleared2015: 1 descendant cleared2025: 11 descendants cleared2018: 4 descendants cleared2019: 8 descendants cleared2017: 5 descendants cleared2020: 4 descendants cleared2021: 9 descendants cleared2023: 5 descendants cleared2026: 3 descendants cleared2022: 7 descendants cleared2024: 10 descendants clearedK000567 · Ultrasound Scanner Type 2102 · B & K Medical A/S · 2000 · recalledK024236 · Ultrasound Scanner, Type 2400 · B-K Medical A/S · 2003 · recalledK043524 · Ultrasound Scanner Pro Focus, Model 2202 · B-K Medical A/S · 2005 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 3 generations back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 3 descendants4 generations forward: 7 descendants5 generations forward: 14 descendants6 generations forward: 17 descendants7 generations forward: 13 descendants8 generations forward: 10 descendants9 generations forward: 2 descendants10 generations forward: 1 descendant K043524 · Ultrasound Scanner Pro Focus, Model 2202 · B-K Medical A/S · 2005 · recalledK024236 · Ultrasound Scanner, Type 2400 · B-K Medical A/S · 2003 · recalledK000567 · Ultrasound Scanner Type 2102 · B & K Medical A/S · 2000 · recalled0+5+10
  1. Root · 3 generations backK000567 Ultrasound Scanner Type 2102B & K Medical A/S · 2000 · Recalled
  2. 2 generations backK024236 Ultrasound Scanner, Type 2400B-K Medical A/S · 2003 · Recalled
  3. 1 generation backK043524 Ultrasound Scanner Pro Focus, Model 2202B-K Medical A/S · 2005 · Recalled
  4. This deviceK081154 Ultrasound Scanner Flex Focus, Model 1202B-K Medical Aps · 2008
  5. Descendant · cites it directly · 68 of its ownK123254 Ultrasound Scanner Flex FocusB-K Medical Aps · 2013
  6. Descendant · cites it directly · 66 of its ownK132335 Ultrasound Scanner Flex Focus 1202B-K Medical Aps · 2014 · Recalled
  7. Descendant · 2 generations on · 65 of its ownK152763 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
  8. Descendant · 3 generations on · 53 of its ownK162267 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016
  9. Descendant · 4 generations on · 21 of its ownK171233 Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2017

Showing 5 of 76 descendants. See all descendants

Descendants cleared per year

2013: 12014: 22015: 12016: 62017: 52018: 42019: 82020: 42021: 92022: 72023: 52024: 102025: 112026: 3
2013high 11 (2025) · low 1 (2013)2026

Most influential descendants

Showing 5 of 76 · See all
  • K123254Ultrasound Scanner Flex FocusB-K Medical Aps · 2013 · cites it directly68descendants
  • K132335Ultrasound Scanner Flex Focus 1202B-K Medical Aps · 2014 · cites it directly66descendants
  • K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 2 generations on65descendants
  • K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2016 · 3 generations on53descendants
  • K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound SystemShenzhen Mindray Bio-Meidcal Electronics Co., Ltd. · 2017 · 4 generations on21descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K000567Ultrasound Scanner Type 2102B & K Medical A/S20001
−2K024236Ultrasound Scanner, Type 2400B-K Medical A/S20032
−1K043524Ultrasound Scanner Pro Focus, Model 2202B-K Medical A/S20051
0 (this device)K081154Ultrasound Scanner Flex Focus, Model 1202B-K Medical Aps2008—
+1K123254Ultrasound Scanner Flex FocusB-K Medical Aps2013—
+1K132335Ultrasound Scanner Flex Focus 1202B-K Medical Aps20141
+2K152763Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2015—
+3K162267Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2016—
+4K171233Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound…Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201420
201510
201660
201750
201840
201980
202040
202190
202270
202350
2024100
2025110
202630
FIG. 1 — Lineage of K081154, 2000–2026Source: 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), 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. #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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K043524Ultrasound Scanner Pro Focus, Model 2202
Summary page 1
…0) Diagnostic Ultrasonic Transducer (90 ITX, CFR 892.1570) Identification of predicate, legally marketed device: B-K Medical Ultrasound Scanner Pro Focus 2202, K043524 Device description: Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmoni…
B-K Medical A/S20051

Also cleared against K043524: 4 other devices →

What descends from it? (76)

See all 76

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K123254Ultrasound Scanner Flex FocusB-K Medical Aps201368
K132335Ultrasound Scanner Flex Focus 1202B-K Medical Aps201466
K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging20163
K140126Sonic WindowAnalogic Corporation20142

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 8 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
  • 3 of the 5 ancestors have a recall of any class.
  • Of its descendants, K123254 (B-K Medical Aps, 2013) has gone furthest, with 68 descendants of its own.
  • 4 other devices also cite its predicate K043524.

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. 2008, this device’s year, is highlighted.

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—

What is it indicated for?

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Indications for use as stated in the FDA summary.

Also cleared against K043524

4 other devices cite the same predicate.

  • K152467Touch UltrasoundCarestream Health, Inc. · 20152 recalls
  • K143298Ultrasound Scanner System bk2300Bk Medical Aps · 20151 recall
  • K132346Ultrasound Scanner Pro Focus 2202B-K Medical Aps · 2014
  • K100919Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202B-K Medical Aps · 2011

More from B-K Medical Aps

11 FDA decisions under this applicant name. See the company

  • K140428Ultrasound Scanner System BK2300B-K Medical Aps · 20141 recall
  • K132346Ultrasound Scanner Pro Focus 2202B-K Medical Aps · 2014
  • K132335Ultrasound Scanner Flex Focus 1202B-K Medical Aps · 20141 recall
  • K132677Ultrasound Scanner Flex Focus 1202B-K Medical Aps · 2014
  • K132685Ultrasound Scanner Pro Focus 2202B-K Medical Aps · 2014

Recent decisions in IYO

The IYO category page

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  • K253452Accuro 3SRivanna Medical, Inc. · 2026
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https://510kreport.com/device/K081154 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081154: Ultrasound Scanner Flex Focus, Model 1202.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081154

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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