510(k) · Cleared

Cleared

Ultraguide CT-Guide 1010

K002258510(k) TraditionalCleared Aug 8, 200014-day reviewClass II21 CFR 892.1750

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

Ultraguide, Ltd. · JAK System, X-Ray, Tomography, Computed

Cleared on Aug 8, 2000 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 of the 400 devices in its family, counting itself, have a Class I recall. 399 later devices descend from it.

Decided: Aug 8, 2000
Review: 14 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 0

399 later devices descend from it, 6 citing it directly. 7 of the 400 devices in this family, counting this one, have a Class I recall.

This deviceK002258 Ultraguide CT-Guide 1010Ultraguide, Ltd. · 2000
Descendant · cites it directly · 354 of its ownK022354 Ultraguide CTG 2000SAUltraguide, Ltd. · 2002
Descendant · cites it directly · 279 of its ownK013150 MR-Guide 2000Ultraguide, Ltd. · 2001
Descendant · cites it directly · 278 of its ownK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
Descendant · 2 generations on · 222 of its ownK121498 PercunavPhilips Health Care · 2012
Descendant · 3 generations on · 211 of its ownK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled

Showing 5 of 399 descendants. See all descendants

Descendants cleared per year

2001high 35 (2025) · low 0 (2003)2026

Class I recalls in this family

K242670 Lumify Diagnostic Ultrasound System8 generations on · 2025
K242519 Lumify Diagnostic Ultrasound System8 generations on · 2025
K190106 Intra-Operative Positioning System; Simple Curve…12 generations on · 2019
K242133 Intra-Operative Positioning System (IOPS®)…13 generations on · 2024

Most influential descendants

Showing 5 of 399 · See all

K022354Ultraguide CTG 2000SAUltraguide, Ltd. · 2002 · cites it directly354descendants
K013150MR-Guide 2000Ultraguide, Ltd. · 2001 · cites it directly279descendants
K053610AbarisTraxtal Technologies, Inc. · 2006 · cites it directly278descendants
K121498PercunavPhilips Health Care · 2012 · 2 generations on222descendants
K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · 3 generations on211descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002258	Ultraguide CT-Guide 1010	Ultraguide, Ltd.	2000	—
+1	K022354	Ultraguide CTG 2000SA	Ultraguide, Ltd.	2002	—
+1	K013150	MR-Guide 2000	Ultraguide, Ltd.	2001	—
+1	K053610	Abaris	Traxtal Technologies, Inc.	2006	3
+2	K121498	Percunav	Philips Health Care	2012	—
+3	K132304	Epiq Diagnostic Ultrasound System	Philips Ultrasound, Inc.	2013	36

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2004	1	0
2005	3	0
2006	4	0
2007	1	0
2008	5	0
2009	12	0
2010	5	0
2011	9	0
2012	12	0
2013	4	0
2014	18	0
2015	21	0
2016	20	0
2017	34	0
2018	23	0
2019	22	1
2020	33	0
2021	26	0
2022	28	0
2023	24	1
2024	30	2
2025	35	3
2026	27	0

FIG. 1 — Lineage of K002258, 2000–2026Source: 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.

7 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 JAK device

#1 K230223 iCAC Devicescore 23.5 · 12 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? (399)

See all 399

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

Number	Device	Applicant	Decided	Descendants
K022354	Ultraguide CTG 2000SA	Ultraguide, Ltd.	2002	354
K013150	MR-Guide 2000	Ultraguide, Ltd.	2001	279
K053610	Abaris	Traxtal Technologies, Inc.	2006	278
K080624	Navstationirad Emt, Version 1.1	Cas Innovations AG	2008	63
K092619	Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…	Civco	2009	61
K060903	IG4 Image Guided System	Veran Medical Technologies, Inc.	2006	47

Has anything in its family been recalled? (7 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 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 8 generations on · ◆ in the 2025 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 · 12 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 · 13 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 · 13 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 · 13 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 13 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

Nearest 5 of 7; all are on the web page.

What does this lineage say?

Of its descendants, K022354 (Ultraguide, Ltd., 2002) has gone furthest, with 354 descendants of its own.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAK

27in 2025

2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007high 200 (2014) · low 27 (2007)2026

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

Recalls per year · JAK

17in 2025

2007high 51 (2010) · low 5 (2019)2026

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

Adverse event reports per year · JAK

219in 2025

2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, 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	14	27	11	76
2008	26	42	16	120
2009	15	31	29	105
2010	7	92	51	119
2011	16	155	34	205
2012	28	121	23	192
2013	17	132	11	414
2014	30	200	10	308
2015	30	140	28	454
2016	25	129	44	365
2017	29	96	33	338
2018	24	114	10	543
2019	28	94	5	233
2020	30	112	8	177
2021	20	145	15	261
2022	30	131	9	199
2023	27	139	9	310
2024	26	141	20	212
2025	27	141	17	219
2026	21	167	23	—

https://510kreport.com/device/K002258 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002258: Ultraguide CT-Guide 1010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002258

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026