510(k) · Cleared

Cleared

Ultrasound Scanner Flex Focus

K123254510(k) TraditionalCleared Feb 13, 2013118-day reviewClass II21 CFR 892.1550

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 · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Feb 13, 2013 as substantially equivalent to K081154 (B-K Medical Aps, 2008) and 1 other predicate after a 118-day review. Its family tree reaches back 4 generations to 2000. 68 later devices descend from it.

Decided: Feb 13, 2013
Review: 118 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K000567 (2000). 7 ancestors in all. 68 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK000567 Ultrasound Scanner Type 2102B & K Medical A/S · 2000 · Recalled
3 generations backK024236 Ultrasound Scanner, Type 2400B-K Medical A/S · 2003 · Recalled
2 generations backK043524 Ultrasound Scanner Pro Focus, Model 2202B-K Medical A/S · 2005 · Recalled
1 generation backK081154 Ultrasound Scanner Flex Focus, Model 1202B-K Medical Aps · 2008
This deviceK123254 Ultrasound Scanner Flex FocusB-K Medical Aps · 2013
Descendant · cites it directly · 66 of its ownK132335 Ultrasound Scanner Flex Focus 1202B-K Medical Aps · 2014 · Recalled
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
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
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
Descendant · 4 generations on · 20 of its ownK170277 DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

2014high 10 (2024) · low 1 (2014)2026

Most influential descendants

Showing 5 of 68 · See all

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
K170277DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2017 · 4 generations on20descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K000567	Ultrasound Scanner Type 2102	B & K Medical A/S	2000	1
−3	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
−1	K081154	Ultrasound Scanner Flex Focus, Model 1202	B-K Medical Aps	2008	—
0 (this device)	K123254	Ultrasound Scanner Flex Focus	B-K Medical Aps	2013	—
+1	K132335	Ultrasound Scanner Flex Focus 1202	B-K Medical Aps	2014	1
+2	K152763	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound…	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2015	—
+3	K162267	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound…	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2016	—
+4	K171233	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound…	Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.	2017	—
+4	K170277	DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0
2011	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0
2015	1	0
2016	4	0
2017	5	0
2018	3	0
2019	6	0
2020	4	0
2021	9	0
2022	7	0
2023	5	0
2024	10	0
2025	10	0
2026	3	0

FIG. 1 — Lineage of K123254, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

Get a 510(k) Report

What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K081154	Ultrasound Scanner Flex Focus, Model 1202 Summary page 1 …) Diagnostic Ultrasonic Transducer (90 ITX, CFR 892.1570) Identification of predicate, legally marketed device: B-K Medical Ultrasound Scanner Flex Focus 1202, K08 1154 B-K Medical Ultrasound Scanner Pro Focus 2202, K100919 Device description: Flex Focus 1202 supports the following scanning mode…	B-K Medical Aps	2008	—
*	K100919	Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202 Summary page 1 …892.1570) Identification of predicate, legally marketed device: B-K Medical Ultrasound Scanner Flex Focus 1202, K08 1154 B-K Medical Ultrasound Scanner Pro Focus 2202, K100919 Device description: Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (inci.Tissue Harmoni…	B-K Medical Aps	2011	—

Also cleared against K081154: 3 other devices →

What descends from it? (68)

See all 68

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

Number	Device	Applicant	Decided	Descendants
K132335	Ultrasound Scanner Flex Focus 1202	B-K Medical Aps	2014	66
K153620	Enovare Ultrasound System	Oreon Technologies, Inc.	2016	0

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 13 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
3 of the 7 ancestors have a recall of any class.
Of its descendants, K132335 (B-K Medical Aps, 2014) has gone furthest, with 66 descendants of its own.
3 other devices also cite its predicate K081154.

How does its category compare?

All IYN devices

IYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · IYN

57in 2025

2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007high 124 (2025) · low 18 (2008)2026

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

Recalls per year · IYN

10in 2025

2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007high 610 (2025) · low 2 (2008)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)	—

What is it indicated for?

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD,CWD, Color Doppler, Vector Flow Imaging and combined mode imaging. Signal analysis and display. 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 2-0 images into a single 3-0 volume and display this on the screen. An…

Read the full statement (105 words)

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD,CWD, Color Doppler, Vector Flow Imaging and combined mode imaging.

Signal analysis and display.

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 2-0 images into a single 3-0 volume and display this on the screen.

An optional Vector Flow Imaging (WFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.

Clinical applications: Abdominal, Cardiac, Fetal, lntraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small organs, Transvaginal, Musculoskeletal.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K123254 · printed Nov 3, 2026

Cite this page

510(k) Report. “K123254: Ultrasound Scanner Flex Focus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K123254

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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