510(k) · Cleared

Cleared

Visions 2.9F Ultrasonic Imaging Catheter (Model 84300)

K944004510(k) TraditionalCleared May 4, 1995261-day reviewClass II21 CFR 892.1560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Endosonics Corp. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on May 4, 1995 after a 261-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 655 devices in its family, counting itself, have a Class I recall. 654 later devices descend from it.

Decided: May 4, 1995
Review: 261 days
Class: Class II
Product code: IYO
Recalls: None
Predicates: 0

654 later devices descend from it, 5 citing it directly. 6 of the 655 devices in this family, counting this one, have a Class I recall.

This deviceK944004 Visions 2.9F Ultrasonic Imaging Catheter (Model 84300)Endosonics Corp. · 1995
Descendant · cites it directly · 648 of its ownK031148 IN-Vision Imaging SystemJomed, Inc. · 2003
Descendant · cites it directly · 614 of its ownK051920 Volcano S5 Imaging System, Model 804200-001Volcano Corporation · 2005 · Recalled
Descendant · cites it directly · 613 of its ownK061215 Volcano S51 Family of Imaging SystemsVolcano Corporation · 2006
Descendant · 2 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
Descendant · 3 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled

Showing 5 of 654 descendants. See all descendants

Descendants cleared per year

2003high 54 (2020) · low 0 (2004)2026

Class I recalls in this family

K172258 Novasight Hybrid System2 generations on · 2018
K190106 Intra-Operative Positioning System; Simple Curve…6 generations on · 2019
K242133 Intra-Operative Positioning System (IOPS®)…7 generations on · 2024
K241243 Intra-Operative Positioning System (IOPS®)…7 generations on · 2024

Most influential descendants

Showing 5 of 654 · See all

K031148IN-Vision Imaging SystemJomed, Inc. · 2003 · cites it directly648descendants
K051920Volcano S5 Imaging System, Model 804200-001Volcano Corporation · 2005 · cites it directly614descendants
K061215Volcano S51 Family of Imaging SystemsVolcano Corporation · 2006 · cites it directly613descendants
K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 2 generations on582descendants
K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 3 generations on569descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K944004	Visions 2.9F Ultrasonic Imaging Catheter (Model 84300)	Endosonics Corp.	1995	—
+1	K031148	IN-Vision Imaging System	Jomed, Inc.	2003	—
+1	K051920	Volcano S5 Imaging System, Model 804200-001	Volcano Corporation	2005	1
+1	K061215	Volcano S51 Family of Imaging Systems	Volcano Corporation	2006	—
+2	K083095	Sonixtouch Ultrasound System	Ultrasonix Medical Corporation	2008	—
+3	K092271	GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4	GE Healthcare	2009	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	2	0
2006	2	0
2008	4	0
2009	6	0
2010	5	0
2011	12	0
2012	26	0
2013	23	0
2014	38	0
2015	34	0
2016	38	0
2017	52	0
2018	51	1
2019	41	1
2020	54	0
2021	40	0
2022	44	0
2023	43	1
2024	49	2
2025	54	1
2026	35	0

FIG. 1 — Lineage of K944004, 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.

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 IYO device

#1 K243937 Accuro 3Sscore 20.5 · 18 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?

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

What descends from it? (654)

See all 654

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

Number	Device	Applicant	Decided	Descendants
K031148	IN-Vision Imaging System	Jomed, Inc.	2003	648
K051920	Volcano S5 Imaging System, Model 804200-001	Volcano Corporation	2005	614
K061215	Volcano S51 Family of Imaging Systems	Volcano Corporation	2006	613
K071554	Volcano S5/S5I Intravascular Imaging and Pressure System	Volcano Corporation	2008	28
K150442	Volcano Visions PV .018 Digital IVUS Catheter	Volcano Corporation	2015	5

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.

K172258Novasight Hybrid SystemConavi Medical, Inc. · 2018 · 2 generations on · ◆ in the 2018 descendants bar of FIG. 11 Class I recall
K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 7 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

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

What does this lineage say?

Of its descendants, K031148 (Jomed, Inc., 2003) has gone furthest, with 648 descendants of its own.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYO

7in 2025

2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007high 220 (2024) · low 17 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYO

1in 2022

2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, 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	20	17	4	39
2008	14	36	5	20
2009	13	79	9	27
2010	15	113	8	20
2011	11	69	0	58
2012	15	68	2	78
2013	17	50	3	436
2014	14	63	2	304
2015	19	46	1	268
2016	10	36	0	254
2017	19	72	0	238
2018	14	56	1	368
2019	13	59	1	537
2020	11	57	0	498
2021	15	64	11	617
2022	5	190	1	511
2023	11	177	0	527
2024	10	220	0	640
2025	7	171	0	485
2026	10	139	1	—

https://510kreport.com/device/K944004 · printed Nov 5, 2026

Cite this page

510(k) Report. “K944004: Visions 2.9F Ultrasonic Imaging Catheter (Model 84300).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944004

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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