510(k) · Cleared

Recalled · Class III · 2025

HP Sonos Ultrasound Imaging System

K954028510(k) TraditionalCleared Aug 8, 1996346-day reviewClass II21 CFR 892.1550Recalls 2

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 Aug 8, 1996 as substantially equivalent to K935009 (Advanced Technology Laboratories, Inc., 1994) and 1 other predicate after a 346-day review. Its family tree reaches back 1 generation to 1994. 192 later devices descend from it. It has been recalled 2 times.

Decided: Aug 8, 1996
Review: 346 days
Class: Class II
Product code: IYN
Recalls: 2
Predicates: 2

Its longest line of descent runs back 1 generation to K935009 (1994). 2 ancestors in all. 192 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK935009 PegasusAdvanced Technology Laboratories, Inc. · 1994
This deviceK954028 HP Sonos Ultrasound Imaging SystemHewlett-Packard Co. · 1996
Descendant · cites it directly · 190 of its ownK972348 HP Endovaginal/Endorectal Probe, HP Image Point Ultrasound SystemHewlett-Packard Co. · 1997 · Recalled
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 192 descendants. See all descendants

Descendants cleared per year

1997high 25 (2017) · low 0 (1998)2026

Most influential descendants

Showing 5 of 192 · See all

K972348HP Endovaginal/Endorectal Probe, HP Image Point Ultrasound SystemHewlett-Packard Co. · 1997 · 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
−1	K935009	Pegasus	Advanced Technology Laboratories, Inc.	1994	—
0 (this device)	K954028	HP Sonos Ultrasound Imaging System	Hewlett-Packard Co.	1996	—
+1	K972348	HP Endovaginal/Endorectal Probe, HP Image Point Ultrasound System	Hewlett-Packard Co.	1997	1
+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	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	2	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 K954028, 1994–2026Source: 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? (2)

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
*	K935009	Pegasus Summary page 1 …cho Imaging System 892.1570 Diagnostic Ultrasonic Transducer In this 510(k) submission, the legally marketed devices to which we claim equivalence are the ATL HDI 3000 (K935009) and the Toshiba SSA-380A (K933743) ultrasound imaging systems. Device Description: The modification addressed in this submissio…	Advanced Technology Laboratories, Inc.	1994	—
*	K933743	SSA-380A Summary page 1 …tic Ultrasonic Transducer In this 510(k) submission, the legally marketed devices to which we claim equivalence are the ATL HDI 3000 (K935009) and the Toshiba SSA-380A (K933743) ultrasound imaging systems. Device Description: The modification addressed in this submission is a change from analog to digita…	Toshiba America Medical Systems, In.C	1994	—

Also cleared against K935009: 3 other devices →

What descends from it? (192)

See all 192

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

Number	Device	Applicant	Decided	Descendants
K972348	HP Endovaginal/Endorectal Probe, HP Image Point Ultrasound System	Hewlett-Packard Co.	1997	190
K990400	Linear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging System	Hewlett-Packard Co.	1999	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 3, 2025	Class III	Z-2387-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Jul 3, 2025	Class III	Z-2388-2025	Device Design	To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K972348 (Hewlett-Packard Co., 1997) has gone furthest, with 190 descendants of its own.
3 other devices also cite its predicate K935009.

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?

This modification has no effect on intended use of the HP ultrasound systems.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K954028 · printed Nov 6, 2026

Cite this page

510(k) Report. “K954028: HP Sonos Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954028

Report an extraction error

Are you the manufacturer?

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