510(k) · Cleared

Cleared

Sonos 2000, Sonos 2500 (M2406 a)

K964309510(k) TraditionalCleared Apr 22, 1997175-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 Apr 22, 1997 as substantially equivalent to K934041 (Hewlett-Packard Co., 1994) and 1 other predicate after a 175-day review. Its family tree reaches back 1 generation to 1994. 3 of the 1,027 devices in its family, counting itself, have a Class I recall. 1,024 later devices descend from it.

Decided: Apr 22, 1997
Review: 175 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K934041 (1994). 2 ancestors in all. 1,024 later devices descend from it, 4 citing it directly. 3 of the 1,027 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK934041 Hewlett Packard Conos Ultrasound Imaging System ModificationHewlett-Packard Co. · 1994
This deviceK964309 Sonos 2000, Sonos 2500 (M2406 a)Hewlett-Packard Co. · 1997
Descendant · cites it directly · 899 of its ownK982800 Ecton Lynx Ultrasound SystemEcton, Inc. · 1998
Descendant · 2 generations on · 898 of its ownK021497 Cypress Ultrasound SystemAcuson Corp. · 2002 · Recalled
Descendant · 3 generations on · 827 of its ownK042055 Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
Descendant · 4 generations on · 806 of its ownK052021 V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · Recalled
Descendant · 5 generations on · 802 of its ownK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006

Showing 5 of 1,024 descendants. See all descendants

Descendants cleared per year

1998high 87 (2025) · low 0 (2000)2026

Class I recalls in this family

K193517 ViziShot 2 FLEX9 generations on · 2020
K242670 Lumify Diagnostic Ultrasound System10 generations on · 2025
K242519 Lumify Diagnostic Ultrasound System10 generations on · 2025

Most influential descendants

Showing 5 of 1,024 · See all

K982800Ecton Lynx Ultrasound SystemEcton, Inc. · 1998 · cites it directly899descendants
K021497Cypress Ultrasound SystemAcuson Corp. · 2002 · 2 generations on898descendants
K042055Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · 3 generations on827descendants
K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · 4 generations on806descendants
K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · 5 generations on802descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K934041	Hewlett Packard Conos Ultrasound Imaging System Modification	Hewlett-Packard Co.	1994	—
0 (this device)	K964309	Sonos 2000, Sonos 2500 (M2406 a)	Hewlett-Packard Co.	1997	—
+1	K982800	Ecton Lynx Ultrasound System	Ecton, Inc.	1998	—
+2	K021497	Cypress Ultrasound System	Acuson Corp.	2002	2
+3	K042055	Cypress Ultrasound System	Siemens Medical Solutions USA, Inc.	2004	—
+4	K052021	V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer	Siemens Medical Solutions USA, Inc.	2005	1
+5	K063138	Modification to Acuson Antares Ultrasound System	Siemens Medical Solutions USA, Inc.	2006	—

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
1998	3	0
1999	4	0
2001	2	0
2002	3	0
2003	2	0
2004	3	0
2005	7	0
2006	3	0
2007	10	0
2008	11	0
2009	18	0
2010	12	0
2011	24	0
2012	37	0
2013	39	0
2014	56	0
2015	59	0
2016	68	0
2017	77	0
2018	68	0
2019	56	0
2020	78	1
2021	56	0
2022	60	0
2023	61	0
2024	63	0
2025	87	2
2026	57	0

FIG. 1 — Lineage of K964309, 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.

3 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? (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
*	K934041	Hewlett Packard Conos Ultrasound Imaging System Modification Summary page 1 …Device: There are two predicate devices used for this submittal. One predicate device for this submittal is the existing SONOS 2500 system which was reviewed by FDA with K934041 and found to be SE on September 22, 1994. The second predicate device is the ATL HDI 3000 system which was reviewed by FDA with K…	Hewlett-Packard Co.	1994	—
*	K935009	Pegasus Summary page 1 …em which was reviewed by FDA with K934041 and found to be SE on September 22, 1994. The second predicate device is the ATL HDI 3000 system which was reviewed by FDA with K935009 and found to be SE on October 11,1994 4) Description of the device or modification being submitted for premarket approval. Func…	Advanced Technology Laboratories, Inc.	1994	—

Also cleared against K934041: 2 other devices →

What descends from it? (1,024)

See all 1,024

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

Number	Device	Applicant	Decided	Descendants
K982800	Ecton Lynx Ultrasound System	Ecton, Inc.	1998	899
K981397	Harmonic Imaging and Flash Echo Imaging Function for the Diagnostic Ultrasound System…	Toshiba America Medical Systems, In.C	1998	403
K980687	Sonos 5500 Ultrasound Imaging System	Hewlett-Packard Co.	1998	1
K990400	Linear Array Transducer,Model HP 21376, M2410A Ultrasound Imaging System	Hewlett-Packard Co.	1999	0

Has anything in its family been recalled? (3 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.

K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 9 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K982800 (Ecton, Inc., 1998) has gone furthest, with 899 descendants of its own.
2 other devices also cite its predicate K934041.

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/K964309 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964309: Sonos 2000, Sonos 2500 (M2406 a).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964309

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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