510(k) · Cleared

Cleared

Ziehm Vision

K011292510(k) TraditionalCleared Jun 20, 200151-day reviewClass II21 CFR 892.1650

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

Ziehm International, Inc. · OWB Interventional Fluoroscopic X-Ray System

Cleared on Jun 20, 2001 after a 51-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 36 later devices descend from it.

Decided: Jun 20, 2001
Review: 51 days
Class: Class II
Product code: OWB
Recalls: None
Predicates: 0

36 later devices descend from it, 3 citing it directly.

This deviceK011292 Ziehm VisionZiehm International, Inc. · 2001
Descendant · cites it directly · 34 of its ownK061534 Ziehm Vision FD Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006
Descendant · cites it directly · 28 of its ownK073346 Ziehm Vision 2Ziehm Imaging, Inc. · 2008 · Recalled
Descendant · cites it directly · 18 of its ownK061203 Ziehm Vision R Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006 · Recalled
Descendant · 2 generations on · 17 of its ownK083545 Ziehm Vision RFDZiehm Imaging, Inc. · 2009 · Recalled
Descendant · 3 generations on · 16 of its ownK132904 Ziehm Vision RFDZiehm Imaging GmbH · 2013 · Recalled

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2006high 7 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 36 · See all

K061534Ziehm Vision FD Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006 · cites it directly34descendants
K073346Ziehm Vision 2Ziehm Imaging, Inc. · 2008 · cites it directly28descendants
K061203Ziehm Vision R Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006 · cites it directly18descendants
K083545Ziehm Vision RFDZiehm Imaging, Inc. · 2009 · 2 generations on17descendants
K132904Ziehm Vision RFDZiehm Imaging GmbH · 2013 · 3 generations on16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K011292	Ziehm Vision	Ziehm International, Inc.	2001	—
+1	K061534	Ziehm Vision FD Digital Mobile Imaging System	Ziehm Imaging, Inc.	2006	—
+1	K073346	Ziehm Vision 2	Ziehm Imaging, Inc.	2008	5
+1	K061203	Ziehm Vision R Digital Mobile Imaging System	Ziehm Imaging, Inc.	2006	4
+2	K083545	Ziehm Vision RFD	Ziehm Imaging, Inc.	2009	3
+3	K132904	Ziehm Vision RFD	Ziehm Imaging GmbH	2013	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2008	1	0
2009	2	0
2013	1	0
2015	1	0
2016	1	0
2019	3	0
2020	3	0
2021	4	0
2022	1	0
2023	4	0
2024	3	0
2025	7	0
2026	3	0

FIG. 1 — Lineage of K011292, 2001–2026Source: 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.

Planning a device in OWB? 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 OWB device

#1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (36)

See all 36

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

Number	Device	Applicant	Decided	Descendants
K061534	Ziehm Vision FD Digital Mobile Imaging System	Ziehm Imaging, Inc.	2006	34
K073346	Ziehm Vision 2	Ziehm Imaging, Inc.	2008	28
K061203	Ziehm Vision R Digital Mobile Imaging System	Ziehm Imaging, Inc.	2006	18

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K061534 (Ziehm Imaging, Inc., 2006) has gone furthest, with 34 descendants of its own.

How does its category compare?

All OWB devices

OWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OWB

22in 2025

2007high 24 (2021) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OWB

148in 2025

2007high 221 (2026) · low 37 (2012)2026

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

Recalls per year · OWB

42so far in 2026, the most since 2007

2007high 42 (2026) · low 0 (2007)2026

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

Adverse event reports per year · OWB

14,008in 2025

2007high 14,008 (2025) · low 0 (2008)2025

MAUDE reports naming product code OWB, 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	3	52	0	1
2008	4	135	1	0
2009	9	99	0	0
2010	7	66	0	0
2011	6	79	0	1
2012	6	37	0	1
2013	11	119	10	27
2014	15	158	9	103
2015	11	66	35	2,134
2016	16	103	13	4,074
2017	20	76	13	1,604
2018	23	54	6	1,449
2019	9	174	7	1,558
2020	16	53	8	1,581
2021	24	60	31	1,981
2022	21	90	24	2,932
2023	12	152	22	7,604
2024	13	126	11	7,942
2025	22	148	30	14,008
2026	15	221	42	—

https://510kreport.com/device/K011292 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011292: Ziehm Vision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011292

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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