510(k) · Cleared
ClearedC-Mount Objective Lens F = 17 MM, Steam-Sterilizable: Model 85 261.172, C-Mount Objective Lens F = 21 MM, Steam-Steriliz
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Dec 13, 1996 after a 56-day review. The FDA summary names its predicate without a number. 11 later devices descend from it.
- Decided
- Dec 13, 1996
- Review
- 56 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK964173 C-Mount Objective Lens F = 17 MM, Steam-Sterilizable: Model 85…Richard Wolf Medical Instruments Corp. · 1996
- Descendant · cites it directly · 10 of its ownK023659 1-CCD Endocam 5520 SystemRichard Wolf Medical Instruments Corp. · 2003
- Descendant · 2 generations on · 7 of its ownK080977 3 CCD Endocam 5550Richard Wolf Medical Instruments Corp. · 2008
- Descendant · cites it directly · 6 of its ownK130423 The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013
- Descendant · 2 generations on · 4 of its ownK180583 Logic 4K Camera Controller, Logic 4K Camera HeadRichard Wolf Medical Instruments Corporation · 2018
- Descendant · 3 generations on · 2 of its ownK200617 Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic…Richard Wolf Medical Instruments Corporation · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K0236591-CCD Endocam 5520 SystemRichard Wolf Medical Instruments Corp. · 2003 · cites it directly10descendants
- K0809773 CCD Endocam 5550Richard Wolf Medical Instruments Corp. · 2008 · 2 generations on7descendants
- K130423The Richard Wolf Endocam Logic HD Camera System 5525Richard Wolf Medical Instruments Corp. · 2013 · cites it directly6descendants
- K180583Logic 4K Camera Controller, Logic 4K Camera HeadRichard Wolf Medical Instruments Corporation · 2018 · 2 generations on4descendants
- K200617Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller…Richard Wolf Medical Instruments Corporation · 2020 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964173 | C-Mount Objective Lens F = 17 MM, Steam-Sterilizable: Model 85 261.172… | Richard Wolf Medical Instruments Corp. | 1996 | — |
| +1 | K023659 | 1-CCD Endocam 5520 System | Richard Wolf Medical Instruments Corp. | 2003 | — |
| +2 | K080977 | 3 CCD Endocam 5550 | Richard Wolf Medical Instruments Corp. | 2008 | — |
| +1 | K130423 | The Richard Wolf Endocam Logic HD Camera System 5525 | Richard Wolf Medical Instruments Corp. | 2013 | — |
| +2 | K180583 | Logic 4K Camera Controller, Logic 4K Camera Head | Richard Wolf Medical Instruments Corporation | 2018 | — |
| +3 | K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera… | Richard Wolf Medical Instruments Corporation | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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 FET? 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 FET device
- #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | — | RIWO lenses f = 15 mm, 30 mm, 60 mm, Model no. 5400/15, 5400/30, 5400/60 Named without a submission number | |
| * | — | C-mount lenses f = 25 mm, 38 mm, Model no. 20230041, 20230043 Named without a submission number | |
| * | — | Coupler 28 mm, 35 mm, Model no. 88-9714, 88-9715 Named without a submission number |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K023659 (Richard Wolf Medical Instruments Corp., 2003) has gone furthest, with 10 descendants of its own.
How does its category compare?
All FET devicesFET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FET
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FET
166in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FET
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FET
14,530in 2025
MAUDE reports naming product code FET, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 25 |
| 2017 | 3 | 119 | 0 | 66 |
| 2018 | 3 | 98 | 0 | 67 |
| 2019 | 3 | 25 | 0 | 72 |
| 2020 | 5 | 106 | 0 | 3,043 |
| 2021 | 1 | — | 0 | 5,300 |
| 2022 | 2 | — | 0 | 6,156 |
| 2023 | 1 | — | 2 | 8,199 |
| 2024 | 2 | — | 1 | 13,153 |
| 2025 | 6 | 166 | 0 | 14,530 |
| 2026 | 3 | 69 | 0 | — |
What is it indicated for?
The C-Mount objective lenses serve to connect endoscope to video cameras.
The lenses with clamping mechanism are used for video-controlled diagnostics and therapy and allow quick adaptation and fixation of the standard telescopes with eyepiece.
The focus ring serves to focus an endoscopic image on the monitor.
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/K964173 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964173: C-Mount Objective Lens F = 17 MM, Steam-Sterilizable: Model 85 261.172, C-Mount Objective Lens F = 21 MM, Steam-Steriliz.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964173
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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