510(k) · Cleared
ClearedEndofix Exo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aktormed GmbH · OCV Endoscope Holder
Cleared on Apr 25, 2024 as substantially equivalent to K190576 (Biomet Microfixation, 2019) after a 259-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Apr 25, 2024
- Review
- 259 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 deviceK232405 Endofix ExoAktormed GmbH · 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) | K232405 | Endofix Exo | Aktormed GmbH | 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 K240506 KARL STORZ Holdersscore 9.4 · 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…lation Number 876.1500 Product Code OCV 4. Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # K190576 Predicate Trade Name WalterLorenz Surgical Assist Arm Scope Holder (Primary Predicate is listed first) Product Co… | 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 4.9 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 ENDOFIX EXO is indicated for use in interventions where a rigid endoscope / exoscope is indicated for use. The device is intended to hold and position a rigid endoscope / exoscope during general and neurological diagnostic and therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232405: Endofix Exo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232405
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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