510(k) · Cleared
ClearedKARL STORZ Holders
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz Endoscopy America, Inc. · OCV Endoscope Holder
Cleared on Oct 22, 2024 as substantially equivalent to K190576 (Biomet Microfixation, 2019) after a 244-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Oct 22, 2024
- Review
- 244 days
- Class
- Class II
- Product code
- OCV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945572 (1995). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK945572 Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352Johnson & Johnson Professionals, Inc. · 1995
- 4 generations backK992006 Neuroview Instrument Holder, Model 300-33Integra Neurocare, LLC · 1999
- 3 generations backK050051 Armand Endoscope HolderKLS-Martin L.P. · 2005
- 2 generations backK070509 Fisso Holding SystemBaitella AG · 2007
- 1 generation backK190576 WalterLorenz Surgical Assist Arm Scope HolderBiomet Microfixation · 2019
- This deviceK240506 KARL STORZ HoldersKarl Storz Endoscopy America, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945572 | Codman (R) Ridig and Steerable Endoscope Holder, Model 83-1352 | Johnson & Johnson Professionals, Inc. | 1995 | — |
| −4 | K992006 | Neuroview Instrument Holder, Model 300-33 | Integra Neurocare, LLC | 1999 | — |
| −3 | K050051 | Armand Endoscope Holder | KLS-Martin L.P. | 2005 | — |
| −2 | K070509 | Fisso Holding System | Baitella AG | 2007 | — |
| −1 | K190576 | WalterLorenz Surgical Assist Arm Scope Holder | Biomet Microfixation | 2019 | — |
| 0 (this device) | K240506 | KARL STORZ Holders | Karl Storz Endoscopy America, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1999 | 1 | 0 |
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 K232405 Endofix Exoscore 8.4 · 5 generations · no Class I recall
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K190576 | WalterLorenz Surgical Assist Arm Scope HolderSummary page 5…rt 876.1500); Regulatory 2 Class: Product Code: Primary: OCV Secondary: GCJ Predicate Walterlorenz Surgical Assist Arm Scope Holder (K190576) Devices: Device The KARL STORZ Holder is a manually operated surgical instrument intended to hold scopes (such as end… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 5.4 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K190576.
How does its category compare?
All OCV devicesOCV Endoscope Holder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · OCV
2in 2024
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KARL STORZ Holders are manually operated surgical devices intended to hold endoscopes (such as arthroscopes, etc) and accessories during general and neurologic diagnostic and therapeutic 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/K240506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240506: KARL STORZ Holders.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240506
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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