510(k) · Cleared
ClearedAutoclavable Camer Head Model Otv-Y0017
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Oct 8, 2010 as substantially equivalent to K083155 (Olympus Medical Systems Corporation, 2009) after a 78-day review. Its family tree reaches back 2 generations to 1996. 10 later devices descend from it.
- Decided
- Oct 8, 2010
- Review
- 78 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955404 (1996). 10 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK955404 Otv-S5 Oes Video SystemOlympus America, Inc. · 1996
- 1 generation backK083155 HD Camera Head Otv-S7PROH-HD-L08EOlympus Medical Systems Corporation · 2009
- This deviceK102059 Autoclavable Camer Head Model Otv-Y0017Olympus Medical Systems Corporation · 2010
- Descendant · cites it directly · 5 of its ownK190449 Visera Elite II Video System Center, Visera Elite II HD 3CMOS…Olympus Medical Systems Corp. · 2019
- Descendant · cites it directly · 3 of its ownK151011 Visera 4K Uhd SystemOlympus Medical Systems Corp. · 2015
- Descendant · 2 generations on · 2 of its ownK242067 Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite…Olympus Corporations of the Americas · 2025
- Descendant · 3 generations on · 0 of its ownK262079 4K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp. · 2026
- Descendant · 2 generations on · 0 of its ownK261260 HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems Corporation · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K190449Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head…Olympus Medical Systems Corp. · 2019 · cites it directly5descendants
- K151011Visera 4K Uhd SystemOlympus Medical Systems Corp. · 2015 · cites it directly3descendants
- K242067Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led Light Source…Olympus Corporations of the Americas · 2025 · 2 generations on2descendants
- K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp. · 2026 · 3 generations on0descendants
- K261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems Corporation · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955404 | Otv-S5 Oes Video System | Olympus America, Inc. | 1996 | — |
| −1 | K083155 | HD Camera Head Otv-S7PROH-HD-L08E | Olympus Medical Systems Corporation | 2009 | — |
| 0 (this device) | K102059 | Autoclavable Camer Head Model Otv-Y0017 | Olympus Medical Systems Corporation | 2010 | — |
| +1 | K190449 | Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable… | Olympus Medical Systems Corp. | 2019 | — |
| +1 | K151011 | Visera 4K Uhd System | Olympus Medical Systems Corp. | 2015 | — |
| +2 | K242067 | Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led… | Olympus Corporations of the Americas | 2025 | — |
| +3 | K262079 | 4K Camera Head OLYMPUS CH-S700-08-LB | Olympus Medical Systems Corp. | 2026 | — |
| +2 | K261260 | HD Camera Head OLYMPUS CH-S200-08-LB | Olympus Medical Systems Corporation | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K083155 | HD Camera Head Otv-S7PROH-HD-L08ESummary page 2…Nishishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No: 3002808148 * 510(k)No. K083155 4 Device Description AUTOCLAVABLE CAMERA HEAD OTV-Y0017 is an imaging device used with specified Olympus video system center, l… | 2009 |
What descends from it? (10)
2 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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 13.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K190449 (Olympus Medical Systems Corp., 2019) has gone furthest, with 5 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. 2010, this device’s year, is highlighted.
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?
This camera head has been designed to be used with the CV- 1S0 EXERA II video system center or OTV-S7Pro VISERA Pro video system center, endloscopes, light sources, video monitors and other ancillary equipment for endoscopic diagnosis and treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102059: Autoclavable Camer Head Model Otv-Y0017.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102059
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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