510(k) · Cleared

Cleared

Ultrasound 77030 Imaging System

K944048510(k) TraditionalCleared Mar 1, 1995195-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

Hewlett-Packard Co. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Mar 1, 1995 after a 195-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 191 later devices descend from it.

Decided: Mar 1, 1995
Review: 195 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 0

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

This deviceK944048 Ultrasound 77030 Imaging SystemHewlett-Packard Co. · 1995
Descendant · cites it directly · 190 of its ownK971116 Sonos 5500 Imaging SystemHewlett-Packard Co. · 1998
Descendant · 2 generations on · 189 of its ownK990339 Sonos 5500 Imaging System M2424A Version B.OHewlett-Packard Co. · 1999 · Recalled
Descendant · 3 generations on · 188 of its ownK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
Descendant · 4 generations on · 182 of its ownK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
Descendant · 4 generations on · 180 of its ownK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008

Showing 5 of 191 descendants. See all descendants

Descendants cleared per year

1998high 25 (2017) · low 0 (2000)2026

Most influential descendants

Showing 5 of 191 · See all

K971116Sonos 5500 Imaging SystemHewlett-Packard Co. · 1998 · cites it directly190descendants
K990339Sonos 5500 Imaging System M2424A Version B.OHewlett-Packard Co. · 1999 · 2 generations on189descendants
K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · 3 generations on188descendants
K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 4 generations on182descendants
K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 4 generations on180descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K944048	Ultrasound 77030 Imaging System	Hewlett-Packard Co.	1995	—
+1	K971116	Sonos 5500 Imaging System	Hewlett-Packard Co.	1998	—
+2	K990339	Sonos 5500 Imaging System M2424A Version B.O	Hewlett-Packard Co.	1999	1
+3	K072164	DC-6 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2007	—
+4	K080640	M5 Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2008	—
+4	K081320	DC-3, DC-3T Diagnostic Ultrasound System	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2007	1	0
2008	4	0
2009	3	0
2010	6	0
2011	9	0
2012	6	0
2013	9	0
2014	2	0
2015	17	0
2016	10	0
2017	25	0
2018	12	0
2019	11	0
2020	13	0
2021	10	0
2022	9	0
2023	8	0
2024	13	0
2025	15	0
2026	6	0

FIG. 1 — Lineage of K944048, 1995–2026Source: 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 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?

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

What descends from it? (191)

See all 191

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

Number	Device	Applicant	Decided	Descendants
K971116	Sonos 5500 Imaging System	Hewlett-Packard Co.	1998	190

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, K971116 (Hewlett-Packard Co., 1998) has gone furthest, with 190 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/K944048 · printed Nov 5, 2026

Cite this page

510(k) Report. “K944048: Ultrasound 77030 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/K944048

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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