510(k) · Cleared

Recalled · Class II · 2022

GE Marlin Ultrasound

K033139510(k) SpecialCleared Oct 23, 200323-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 Oct 23, 2003 as substantially equivalent to K020789 (General Electric Co., 2002) after a 23-day review. Its family tree reaches back 2 generations to 2000. 350 later devices descend from it. It has been recalled once.

Decided: Oct 23, 2003
Review: 23 days
Class: Class II
Product code: IYN
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K000695 (2000). 350 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK000695 GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler…Ge Medical Systems, Inc. · 2000
1 generation backK020789 GE Vivid 3 Expert; GE Vivid 3 ProGeneral Electric Co. · 2002
This deviceK033139 GE Marlin UltrasoundGeneral Electric Co. · 2003
Descendant · cites it directly · 349 of its ownK061525 GE Vivid - IGeneral Electric Co. · 2006 · Recalled
Descendant · 2 generations on · 286 of its ownK082374 Vivid I and Vivid QGe Medical Systems Israel, Ultrasound, Ltd. · 2008 · Recalled
Descendant · 3 generations on · 285 of its ownK092140 GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic UltrasoundGe Medical Systems Israel, Ultrasound, Ltd. · 2009 · Recalled
Descendant · 4 generations on · 284 of its ownK102388 Vivid I Diagnostic Ultrasound SystemGe Medical System Israel, Ltd. · 2010 · Recalled
Descendant · 5 generations on · 253 of its ownK120201 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2012 · Recalled

Showing 5 of 350 descendants. See all descendants

Descendants cleared per year

2006high 42 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 350 · See all

K061525GE Vivid - IGeneral Electric Co. · 2006 · cites it directly349descendants
K082374Vivid I and Vivid QGe Medical Systems Israel, Ultrasound, Ltd. · 2008 · 2 generations on286descendants
K092140GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic UltrasoundGe Medical Systems Israel, Ultrasound, Ltd. · 2009 · 3 generations on285descendants
K102388Vivid I Diagnostic Ultrasound SystemGe Medical System Israel, Ltd. · 2010 · 4 generations on284descendants
K120201GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2012 · 5 generations on253descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K000695	GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler Imaging…	Ge Medical Systems, Inc.	2000	—
−1	K020789	GE Vivid 3 Expert; GE Vivid 3 Pro	General Electric Co.	2002	—
0 (this device)	K033139	GE Marlin Ultrasound	General Electric Co.	2003	—
+1	K061525	GE Vivid - I	General Electric Co.	2006	1
+2	K082374	Vivid I and Vivid Q	Ge Medical Systems Israel, Ultrasound, Ltd.	2008	2
+3	K092140	GE Vivid I Diagnostic Ultrasound, GE Vivid Q Diagnostic Ultrasound	Ge Medical Systems Israel, Ultrasound, Ltd.	2009	2
+4	K102388	Vivid I Diagnostic Ultrasound System	Ge Medical System Israel, Ltd.	2010	2
+5	K120201	GE Vivid E9 Diagnostic Ultrasound Imaging System	Ge Vingmed Ultrasound AS	2012	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	2	0
2009	2	0
2010	1	0
2011	1	0
2012	4	0
2013	2	0
2014	5	0
2015	17	0
2016	15	0
2017	27	0
2018	25	0
2019	22	0
2020	32	0
2021	27	0
2022	32	0
2023	25	0
2024	38	0
2025	42	0
2026	30	0

FIG. 1 — Lineage of K033139, 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

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K020789	GE Vivid 3 Expert; GE Vivid 3 Pro Summary page 1 …Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN 3. Marketed Device: GE Vivid 3 Ultrasound System, 51O(k) Number K020789, a device currently in commercial distribution. 4. Device Description: The GE Marlin is a full featured echocardiographysystem in…	General Electric Co.	2002	—

Also cleared against K020789: 3 other devices →

What descends from it? (350)

See all 350

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

Number	Device	Applicant	Decided	Descendants
K061525	GE Vivid - I	General Electric Co.	2006	349

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 10, 2022	Class II	Z-0756-2023	Device Design	Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K061525 (General Electric Co., 2006) has gone furthest, with 349 descendants of its own.
3 other devices also cite its predicate K020789.

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; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033139 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033139: GE Marlin Ultrasound.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033139

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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