510(k) · Cleared

Cleared

GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler Imaging System

K000695510(k) TraditionalCleared Mar 16, 200015-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

Ge Medical Systems, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Mar 16, 2000 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 488 later devices descend from it.

Decided: Mar 16, 2000
Review: 15 days
Class: Class II
Product code: IYO
Recalls: None
Predicates: 0

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

This deviceK000695 GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler…Ge Medical Systems, Inc. · 2000
Descendant · cites it directly · 487 of its ownK020789 GE Vivid 3 Expert; GE Vivid 3 ProGeneral Electric Co. · 2002
Descendant · 2 generations on · 412 of its ownK071985 GE Vivid S5 and S6 Diagnostic UltrasoundGeneral Electric Co. · 2007 · Recalled
Descendant · 2 generations on · 350 of its ownK033139 GE Marlin UltrasoundGeneral Electric Co. · 2003 · Recalled
Descendant · 3 generations on · 349 of its ownK061525 GE Vivid - IGeneral Electric Co. · 2006 · Recalled
Descendant · 3 generations on · 331 of its ownK092079 Modification to GE Vivid S5 and S6 Diagnostic UltrasoundGe Medical Systems Israel, Ultrasound, Ltd. · 2009 · Recalled

Showing 5 of 488 descendants. See all descendants

Descendants cleared per year

2002high 44 (2017) · low 0 (2004)2026

Most influential descendants

Showing 5 of 488 · See all

K020789GE Vivid 3 Expert; GE Vivid 3 ProGeneral Electric Co. · 2002 · cites it directly487descendants
K071985GE Vivid S5 and S6 Diagnostic UltrasoundGeneral Electric Co. · 2007 · 2 generations on412descendants
K033139GE Marlin UltrasoundGeneral Electric Co. · 2003 · 2 generations on350descendants
K061525GE Vivid - IGeneral Electric Co. · 2006 · 3 generations on349descendants
K092079Modification to GE Vivid S5 and S6 Diagnostic UltrasoundGe Medical Systems Israel, Ultrasound, Ltd. · 2009 · 3 generations on331descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	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	—
+2	K071985	GE Vivid S5 and S6 Diagnostic Ultrasound	General Electric Co.	2007	2
+2	K033139	GE Marlin Ultrasound	General Electric Co.	2003	1
+3	K061525	GE Vivid - I	General Electric Co.	2006	1
+3	K092079	Modification to GE Vivid S5 and S6 Diagnostic Ultrasound	Ge Medical Systems Israel, Ultrasound, Ltd.	2009	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2005	1	0
2006	1	0
2007	1	0
2008	2	0
2009	4	0
2010	11	0
2011	12	0
2012	14	0
2013	17	0
2014	12	0
2015	27	0
2016	26	0
2017	44	0
2018	38	0
2019	30	0
2020	40	0
2021	31	0
2022	37	0
2023	27	0
2024	39	0
2025	42	0
2026	30	0

FIG. 1 — Lineage of K000695, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K243937 Accuro 3Sscore 20.5 · 18 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (488)

See all 488

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

Number	Device	Applicant	Decided	Descendants
K020789	GE Vivid 3 Expert; GE Vivid 3 Pro	General Electric Co.	2002	487

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, K020789 (General Electric Co., 2002) has gone furthest, with 487 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

2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007high 220 (2024) · low 17 (2007)2026

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

Recalls per year · IYO

1in 2022

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	20	17	4	39
2008	14	36	5	20
2009	13	79	9	27
2010	15	113	8	20
2011	11	69	0	58
2012	15	68	2	78
2013	17	50	3	436
2014	14	63	2	304
2015	19	46	1	268
2016	10	36	0	254
2017	19	72	0	238
2018	14	56	1	368
2019	13	59	1	537
2020	11	57	0	498
2021	15	64	11	617
2022	5	190	1	511
2023	11	177	0	527
2024	10	220	0	640
2025	7	171	0	485
2026	10	139	1	—

https://510kreport.com/device/K000695 · printed Nov 5, 2026

Cite this page

510(k) Report. “K000695: GE Dolphin Diagnostic Ultrasound System, Ultrasonic Pulsed Doppler Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K000695

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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