510(k) · Cleared

Cleared

Lynx Ultrasound System

K991872510(k) TraditionalCleared Jun 16, 199915-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

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

Cleared on Jun 16, 1999 as substantially equivalent to K934041 (Hewlett-Packard Co., 1994) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1994. 2 of the 902 devices in its family, counting itself, have a Class I recall. 899 later devices descend from it.

Decided: Jun 16, 1999
Review: 15 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. 899 later devices descend from it, 2 citing it directly. 2 of the 902 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 deviceK991872 Lynx Ultrasound SystemEcton, Inc. · 1999
Descendant · cites it directly · 898 of its ownK021497 Cypress Ultrasound SystemAcuson Corp. · 2002 · Recalled
Descendant · 2 generations on · 827 of its ownK042055 Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
Descendant · 3 generations on · 806 of its ownK052021 V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · Recalled
Descendant · 4 generations on · 802 of its ownK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
Descendant · 5 generations on · 801 of its ownK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled

Showing 5 of 899 descendants. See all descendants

Descendants cleared per year

2002high 75 (2025) · low 0 (2003)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 899 · See all

K021497Cypress Ultrasound SystemAcuson Corp. · 2002 · cites it directly898descendants
K042055Cypress Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · 2 generations on827descendants
K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · 3 generations on806descendants
K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · 4 generations on802descendants
K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · 5 generations on801descendants

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)	K991872	Lynx Ultrasound System	Ecton, Inc.	1999	—
+1	K021497	Cypress Ultrasound System	Acuson Corp.	2002	2
+2	K042055	Cypress Ultrasound System	Siemens Medical Solutions USA, Inc.	2004	—
+3	K052021	V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer	Siemens Medical Solutions USA, Inc.	2005	1
+4	K063138	Modification to Acuson Antares Ultrasound System	Siemens Medical Solutions USA, Inc.	2006	—
+5	K063803	Acuson Antares Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc., Ultrasound DI	2007	9

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
2002	2	0
2004	1	0
2005	3	0
2006	2	0
2007	4	0
2008	5	0
2009	9	0
2010	10	0
2011	22	0
2012	29	0
2013	38	0
2014	51	0
2015	53	0
2016	63	0
2017	74	0
2018	65	0
2019	49	0
2020	72	0
2021	51	0
2022	59	0
2023	54	0
2024	57	0
2025	75	2
2026	51	0

FIG. 1 — Lineage of K991872, 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.

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? (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 2 …510(k) submission, the legally marketed devices to which we claim substantial equivalence are: Manufacturer Product K Number Hewlett Packard Co. Sonos 2500 Ultrasound K934041 System ATL, Inc. HDI 3000 Ultrasound K935009 System 4) Device Description The Ecton Lynx Ultrasound System is a general purpos…	Hewlett-Packard Co.	1994	—
*	K935009	Pegasus Summary page 2 …es to which we claim substantial equivalence are: Manufacturer Product K Number Hewlett Packard Co. Sonos 2500 Ultrasound K934041 System ATL, Inc. HDI 3000 Ultrasound K935009 System 4) Device Description The Ecton Lynx Ultrasound System is a general purpose and cardiac diagnostic ultrasound system. It…	Advanced Technology Laboratories, Inc.	1994	—
†	K982800	Ecton Lynx Ultrasound System	Ecton, Inc.	1998	—

Also cleared against K934041: 2 other devices →

What descends from it? (899)

See all 899

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

Number	Device	Applicant	Decided	Descendants
K021497	Cypress Ultrasound System	Acuson Corp.	2002	898
K052331	Acuson Cypress Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	167

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?

None of the 2 ancestors has a recall.
Of its descendants, K021497 (Acuson Corp., 2002) has gone furthest, with 898 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)	—

What is it indicated for?

Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

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/K991872 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991872: Lynx 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/K991872

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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