510(k) · Cleared

Cleared

Philips M2424 Diagnostic Ultrasound System &Philips 21315 Diagnostic Ultrasound Transducer

K022303510(k) TraditionalCleared Jul 30, 200214-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

Philips Ultrasound, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Jul 30, 2002 as substantially equivalent to K002470 (Agilent Technologies, Inc., 2000) and 1 other predicate after a 14-day review. Its family tree reaches back 1 generation to 2000. 6 of the 1,158 devices in its family, counting itself, have a Class I recall. 1,155 later devices descend from it.

Decided: Jul 30, 2002
Review: 14 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K002470 (2000). 2 ancestors in all. 1,155 later devices descend from it, 2 citing it directly. 6 of the 1,158 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK002470 M2424A Sonos 5500/4500 Diagnostic Ultrasound System, Version B.2.…Agilent Technologies, Inc. · 2000
This deviceK022303 Philips M2424 Diagnostic Ultrasound System &Philips 21315 Diagnostic…Philips Ultrasound, Inc. · 2002
Descendant · cites it directly · 979 of its ownK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
Descendant · 2 generations on · 972 of its ownK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
Descendant · cites it directly · 882 of its ownK042540 Philips IU22 Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · Recalled
Descendant · 3 generations on · 838 of its ownK063085 Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
Descendant · 2 generations on · 806 of its ownK052021 V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · Recalled

Showing 5 of 1,155 descendants. See all descendants

Descendants cleared per year

2004high 93 (2025) · low 1 (2004)2026

Class I recalls in this family

K242670 Lumify Diagnostic Ultrasound System7 generations on · 2025
K242519 Lumify Diagnostic Ultrasound System7 generations on · 2025
K162859 Allura Xper FD series and Allura Xper OR Table…8 generations on · 2016
K163715 Allura Xper R98 generations on · 2017

Most influential descendants

Showing 5 of 1,155 · See all

K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · cites it directly979descendants
K052410Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 2 generations on972descendants
K042540Philips IU22 Ultrasound SystemPhilips Ultrasound, Inc. · 2004 · cites it directly882descendants
K063085Modification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · 3 generations on838descendants
K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · 2 generations on806descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002470	M2424A Sonos 5500/4500 Diagnostic Ultrasound System, Version B.2. 21330A…	Agilent Technologies, Inc.	2000	—
0 (this device)	K022303	Philips M2424 Diagnostic Ultrasound System &Philips 21315 Diagnostic…	Philips Ultrasound, Inc.	2002	—
+1	K051139	Acuson Sequoia Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	—
+2	K052410	Acuson Sequoia Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	—
+1	K042540	Philips IU22 Ultrasound System	Philips Ultrasound, Inc.	2004	4
+3	K063085	Modification to Acuson Sequoia Ultrasound System	Siemens Medical Solutions USA, Inc.	2006	3
+2	K052021	V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer	Siemens Medical Solutions USA, Inc.	2005	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	5	0
2006	8	0
2007	12	0
2008	21	0
2009	25	0
2010	25	0
2011	35	0
2012	42	0
2013	52	0
2014	61	0
2015	66	0
2016	70	1
2017	84	2
2018	79	0
2019	56	0
2020	87	1
2021	63	0
2022	69	0
2023	64	0
2024	73	0
2025	93	2
2026	64	0

FIG. 1 — Lineage of K022303, 2000–2026Source: 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.

6 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
*	K002470	M2424A Sonos 5500/4500 Diagnostic Ultrasound System, Version B.2. 21330A Transducer Summary page 1 …n to the separate transducer. It is substantially equivalent to the generic class of ultrasound systems including previous versions of the Philips Medical Systems M2424 (K002470) system and the Voluson 730 (K003525). The 21315 transducer is substantially equivalent to the generic class of ultrasound trans…	Agilent Technologies, Inc.	2000	—
*	K003525	Voluson 730 Diagnostic Ultrasound System Summary page 1 …ubstantially equivalent to the generic class of ultrasound systems including previous versions of the Philips Medical Systems M2424 (K002470) system and the Voluson 730 (K003525). The 21315 transducer is substantially equivalent to the generic class of ultrasound transducers including previously cleared P…	Medison America, Inc.	2000	—

Also cleared against K002470: 1 other device →

What descends from it? (1,155)

See all 1,155

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

Number	Device	Applicant	Decided	Descendants
K051139	Acuson Sequoia Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	979
K042540	Philips IU22 Ultrasound System	Philips Ultrasound, Inc.	2004	882

Has anything in its family been recalled? (6 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 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · 8 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 8 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 9 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 10 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls

Nearest 5 of 6; all are on the web page.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K051139 (Siemens Medical Solutions USA, Inc., 2005) has gone furthest, with 979 descendants of its own.
1 other device also cites its predicate K002470.

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

Diagnostic ultrasound imaging and fluid flow analysis of the human body as

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022303 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022303: Philips M2424 Diagnostic Ultrasound System &Philips 21315 Diagnostic Ultrasound Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022303

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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