510(k) · Cleared

Cleared

Ksea Endoscope Holder

K990334510(k) TraditionalCleared Mar 22, 199947-day reviewClass II21 CFR 876.1500

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

KARL STORZ Endoscopy-America, Inc. · OCV Endoscope Holder

Cleared on Mar 22, 1999 after a 47-day review. The FDA summary names no predicate by number. 38 later devices descend from it.

Decided: Mar 22, 1999
Review: 47 days
Class: Class II
Product code: OCV
Recalls: None
Predicates: 0

38 later devices descend from it, 5 citing it directly.

This deviceK990334 Ksea Endoscope HolderKARL STORZ Endoscopy-America, Inc. · 1999
Descendant · cites it directly · 25 of its ownK051979 Ors Model 6000 Endoscope HolderO.R. Solutions, Inc. · 2005
Descendant · 2 generations on · 23 of its ownK062779 Defogging Heated Endoscope Lens Protector (Dhelp); Defogging…New Wave Surgical Corporation · 2006 · Recalled
Descendant · 3 generations on · 16 of its ownK080613 Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008
Descendant · cites it directly · 10 of its ownK992006 Neuroview Instrument Holder, Model 300-33Integra Neurocare, LLC · 1999
Descendant · cites it directly · 9 of its ownK050051 Armand Endoscope HolderKLS-Martin L.P. · 2005

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

1999high 4 (2024) · low 0 (2000)2026

Most influential descendants

Showing 5 of 38 · See all

K051979Ors Model 6000 Endoscope HolderO.R. Solutions, Inc. · 2005 · cites it directly25descendants
K062779Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector…New Wave Surgical Corporation · 2006 · 2 generations on23descendants
K080613Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC · 2008 · 3 generations on16descendants
K992006Neuroview Instrument Holder, Model 300-33Integra Neurocare, LLC · 1999 · cites it directly10descendants
K050051Armand Endoscope HolderKLS-Martin L.P. · 2005 · cites it directly9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K990334	Ksea Endoscope Holder	KARL STORZ Endoscopy-America, Inc.	1999	—
+1	K051979	Ors Model 6000 Endoscope Holder	O.R. Solutions, Inc.	2005	—
+2	K062779	Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens…	New Wave Surgical Corporation	2006	2
+3	K080613	Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045	Minimally Invasive Devices, LLC	2008	—
+1	K992006	Neuroview Instrument Holder, Model 300-33	Integra Neurocare, LLC	1999	—
+1	K050051	Armand Endoscope Holder	KLS-Martin L.P.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2003	1	0
2005	3	0
2006	2	0
2007	1	0
2008	1	0
2009	1	0
2010	3	0
2014	1	0
2015	2	0
2016	2	0
2017	2	0
2018	2	0
2019	2	0
2020	2	0
2022	3	0
2023	1	0
2024	4	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K990334, 1999–2026Source: 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.

Planning a device in OCV? 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 OCV device

#1 K240506 KARL STORZ Holdersscore 9.4 · 5 generations · no Class I recall
#2 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (38)

See all 38

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

Number	Device	Applicant	Decided	Descendants
K051979	Ors Model 6000 Endoscope Holder	O.R. Solutions, Inc.	2005	25
K992006	Neuroview Instrument Holder, Model 300-33	Integra Neurocare, LLC	1999	10
K050051	Armand Endoscope Holder	KLS-Martin L.P.	2005	9
K190576	WalterLorenz Surgical Assist Arm Scope Holder	Biomet Microfixation	2019	2
K024251	Sightfix	World of Medicine Lemke GmbH	2003	0

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, K051979 (O.R. Solutions, Inc., 2005) has gone furthest, with 25 descendants of its own.

How does its category compare?

All OCV devices

OCV Endoscope Holder: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OCV

2in 2024

2007high 2 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCV

Too few OCV 510(k)s in any year since 2007 to give a median.

Recalls per year · OCV

No recall names OCV since 2007.

Adverse event reports per year · OCV

1in 2025

2007high 2 (2023) · low 0 (2007)2025

MAUDE reports naming product code OCV, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	1	—	0
2010	1	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	1
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	1	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	2
2024	2	—	1
2025	0	—	1
2026	0	—	—

What is it indicated for?

This instrument is a manually operated surgical devices intended for use by qualified surgeons for holding rigid and flexible endoscopes during diagnostic and therapeutic neurologic procedures.

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/K990334 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990334: Ksea Endoscope Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990334

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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