510(k) · Cleared

Cleared

Sonosite Hand-Carried Ultrasound System

K003399510(k) TraditionalCleared Nov 16, 200015-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

Sonosite,Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Nov 16, 2000 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 435 devices in its family, counting itself, have a Class I recall. 434 later devices descend from it.

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

434 later devices descend from it, 1 citing it directly. 2 of the 435 devices in this family, counting this one, have a Class I recall.

This deviceK003399 Sonosite Hand-Carried Ultrasound SystemSonosite,Inc. · 2000
Descendant · cites it directly · 433 of its ownK014116 Hand-Carried Ultrasound SystemSonosite,Inc. · 2001
Descendant · 2 generations on · 339 of its ownK101757 Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series…Sonosite,Inc. · 2010
Descendant · 2 generations on · 124 of its ownK021628 Sonosite Hand-Caried Untrasound System (Powerseries)Sonosite,Inc. · 2002
Descendant · 3 generations on · 116 of its ownK113647 DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2011
Descendant · 4 generations on · 107 of its ownK121010 M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012

Showing 5 of 434 descendants. See all descendants

Descendants cleared per year

2001high 41 (2025) · low 0 (2005)2026

Class I recalls in this family

K242670 Lumify Diagnostic Ultrasound System9 generations on · 2025
K242519 Lumify Diagnostic Ultrasound System9 generations on · 2025

Most influential descendants

Showing 5 of 434 · See all

K014116Hand-Carried Ultrasound SystemSonosite,Inc. · 2001 · cites it directly433descendants
K101757Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound SystemSonosite,Inc. · 2010 · 2 generations on339descendants
K021628Sonosite Hand-Caried Untrasound System (Powerseries)Sonosite,Inc. · 2002 · 2 generations on124descendants
K113647DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2011 · 3 generations on116descendants
K121010M7/M7T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2012 · 4 generations on107descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003399	Sonosite Hand-Carried Ultrasound System	Sonosite,Inc.	2000	—
+1	K014116	Hand-Carried Ultrasound System	Sonosite,Inc.	2001	—
+2	K101757	Sonosite Nanomaxx Series Ultrasound System, Sonosite Maxx Series Ultrasound…	Sonosite,Inc.	2010	—
+2	K021628	Sonosite Hand-Caried Untrasound System (Powerseries)	Sonosite,Inc.	2002	—
+3	K113647	DC-8/DC-8 Pro/DC-8 CV/DC-8 Exp/DC-8S Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2011	—
+4	K121010	M7/M7T Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	2	0
2003	2	0
2004	1	0
2007	1	0
2008	1	0
2009	3	0
2010	2	0
2011	2	0
2012	9	0
2013	14	0
2014	16	0
2015	25	0
2016	27	0
2017	36	0
2018	30	0
2019	29	0
2020	33	0
2021	38	0
2022	30	0
2023	27	0
2024	35	0
2025	41	2
2026	29	0

FIG. 1 — Lineage of K003399, 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.

2 devices in this family have a Class I recall. 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?

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

What descends from it? (434)

See all 434

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

Number	Device	Applicant	Decided	Descendants
K014116	Hand-Carried Ultrasound System	Sonosite,Inc.	2001	433

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K014116 (Sonosite,Inc., 2001) has gone furthest, with 433 descendants of its own.

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)	—

https://510kreport.com/device/K003399 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003399: Sonosite Hand-Carried Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003399

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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