510(k) · Cleared

Recalled · 2006

GE Voluson 730 Pro/Expert Untrasound BT04

K041688510(k) SpecialCleared Jul 8, 200416-day reviewClass II21 CFR 892.1550Recalls 1

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

General Electric Co. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Jul 8, 2004 as substantially equivalent to K003525 (Medison America, Inc., 2000) and 1 other predicate after a 16-day review. Its family tree reaches back 2 generations to 2000. 708 later devices descend from it. It has been recalled once.

Decided: Jul 8, 2004
Review: 16 days
Class: Class II
Product code: IYN
Recalls: 1
Predicates: 2

Its longest line of descent runs back 2 generations to K003525 (2000). 708 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 2 generations backK003525 Voluson 730 Diagnostic Ultrasound SystemMedison America, Inc. · 2000
1 generation backK032620 GE Voluson 730 Pro/Expert BT03 Ultrasound SystemGeneral Electric Co. · 2003
This deviceK041688 GE Voluson 730 Pro/Expert Untrasound BT04General Electric Co. · 2004
Descendant · cites it directly · 554 of its ownK061682 GE Voluson E8 Ultrasound SystemGeneral Electric Co. · 2006 · Recalled
Descendant · 2 generations on · 445 of its ownK101236 Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model…GE Healthcare · 2011
Descendant · cites it directly · 407 of its ownK053435 GE Voluson IGeneral Electric Co. · 2005
Descendant · 3 generations on · 404 of its ownK112213 Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound SystemGE Healthcare · 2011 · Recalled
Descendant · 4 generations on · 402 of its ownK113758 Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012

Showing 5 of 708 descendants. See all descendants

Descendants cleared per year

2005high 62 (2017) · low 0 (2007)2026

Most influential descendants

Showing 5 of 708 · See all

K061682GE Voluson E8 Ultrasound SystemGeneral Electric Co. · 2006 · cites it directly554descendants
K101236Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/ H48681BX/ H48681BMGE Healthcare · 2011 · 2 generations on445descendants
K053435GE Voluson IGeneral Electric Co. · 2005 · cites it directly407descendants
K112213Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound SystemGE Healthcare · 2011 · 3 generations on404descendants
K113758Voluson E6/E8/E8EXPERT/E10GE Healthcare · 2012 · 4 generations on402descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K003525	Voluson 730 Diagnostic Ultrasound System	Medison America, Inc.	2000	—
−1	K032620	GE Voluson 730 Pro/Expert BT03 Ultrasound System	General Electric Co.	2003	—
0 (this device)	K041688	GE Voluson 730 Pro/Expert Untrasound BT04	General Electric Co.	2004	—
+1	K061682	GE Voluson E8 Ultrasound System	General Electric Co.	2006	3
+2	K101236	Voluson E6/E8/E8 Expert Diagnostic Ultrasound System Model: H48681BD/…	GE Healthcare	2011	—
+1	K053435	GE Voluson I	General Electric Co.	2005	—
+3	K112213	Voluson E6, E8, E8 Expert, E10 Diagnostic Ultrasound System	GE Healthcare	2011	1
+4	K113758	Voluson E6/E8/E8EXPERT/E10	GE Healthcare	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2008	4	0
2009	8	0
2010	9	0
2011	18	0
2012	30	0
2013	25	0
2014	41	0
2015	41	0
2016	44	0
2017	62	0
2018	56	0
2019	39	0
2020	56	0
2021	40	0
2022	48	0
2023	43	0
2024	50	0
2025	54	0
2026	38	0

FIG. 1 — Lineage of K041688, 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? (3)

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
*	K003525	Voluson 730 Diagnostic Ultrasound System Summary page 1 …-IYO Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN 3. Marketed Device: Voluson 730 Pro/Expert Diagnostic Ultrasound System K003525, K032620 A device currently in commercial distribution. 4. Device Description: The Voluson 730 Pro/Expert are…	Medison America, Inc.	2000	—
*	K032620	GE Voluson 730 Pro/Expert BT03 Ultrasound System Summary page 1 …Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN 3. Marketed Device: Voluson 730 Pro/Expert Diagnostic Ultrasound System K003525, K032620 A device currently in commercial distribution. 4. Device Description: The Voluson 730 Pro/Expert are full fea…	General Electric Co.	2003	—
*	—	GE Logiq 9 Named without a submission number			—

Also cleared against K003525: 9 other devices →

What descends from it? (708)

See all 708

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

Number	Device	Applicant	Decided	Descendants
K061682	GE Voluson E8 Ultrasound System	General Electric Co.	2006	554
K053435	GE Voluson I	General Electric Co.	2005	407
K091941	DC-3/DC-3T Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2009	177
K101041	DC-7 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2010	130
K110920	UF-760AG	Fukuda Denshi Co., Ltd.	2011	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 24, 2006	Not classified	Z-1172-06	Other	In the cardiac measurement section of the device the calculation of the 'PG Mean' (mean pressure gradient) leads to an erroneous result. It is recommended that customers with affected units do not use the measurement in question 'PG Mean'…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K061682 (General Electric Co., 2006) has gone furthest, with 554 descendants of its own.
9 other devices also cite its predicate K003525.

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.

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?

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal/GYN (including infertility monitoring of follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041688 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041688: GE Voluson 730 Pro/Expert Untrasound BT04.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041688

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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