510(k) · Cleared
ClearedOVS1 Video System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olive Medical Corp. · FCW Light Source, Fiberoptic, Routine
Cleared on Dec 19, 2012 as substantially equivalent to K070716 (KARL STORZ Endoscopy-America, Inc., 2007) and 4 other predicates after a 49-day review. Its family tree reaches back 8 generations to 1983. 1 later device descends from it.
- Decided
- Dec 19, 2012
- Review
- 49 days
- Class
- Class II
- Product code
- FCW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K833587 (1983). 61 ancestors in all, the oldest K771218 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK833587 Disposable Arthroscopy BladeDyonics, Inc. · 1983
- 7 generations backK900070 Modified Uses of the Arthroscopic Surgical SystemDyonics, Inc. · 1990
- 6 generations backK971253 Various Arthroscopes, Endoscopic Blades, Manual InstrumentsSmith & Nephew, Inc. · 1997
- 5 generations backK043395 Smith & Nephew VideoarthroscopeSmith & Nephew, Inc. · 2005
- 4 generations backK072879 Innervue Diagnostic Scope SystemBiomet Orthopedics, Inc. · 2008 · Recalled
- 3 generations backK082293 Surgview Integrated Visualization SystemBiovision Technologies, LLC · 2008
- 2 generations backK093717 C-Mor Visualization DeviceAxis Surgical Technologies, Inc. · 2010
- 1 generation backK102733 Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology…Vision-Sciences, Inc. · 2011
- This deviceK123359 OVS1 Video SystemOlive Medical Corp. · 2012
- Descendant · cites it directly · 0 of its ownK152513 8X-10-XXXX Camera SystemSanta Barbara Imaging Systems · 2015
Most influential descendants
Showing 1 of 1 · See all- K1525138X-10-XXXX Camera SystemSanta Barbara Imaging Systems · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K833587 | Disposable Arthroscopy Blade | Dyonics, Inc. | 1983 | — |
| −7 | K900070 | Modified Uses of the Arthroscopic Surgical System | Dyonics, Inc. | 1990 | — |
| −6 | K971253 | Various Arthroscopes, Endoscopic Blades, Manual Instruments | Smith & Nephew, Inc. | 1997 | — |
| −5 | K043395 | Smith & Nephew Videoarthroscope | Smith & Nephew, Inc. | 2005 | — |
| −4 | K072879 | Innervue Diagnostic Scope System | Biomet Orthopedics, Inc. | 2008 | 2 |
| −3 | K082293 | Surgview Integrated Visualization System | Biovision Technologies, LLC | 2008 | — |
| −2 | K093717 | C-Mor Visualization Device | Axis Surgical Technologies, Inc. | 2010 | — |
| −1 | K102733 | Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology… | Vision-Sciences, Inc. | 2011 | — |
| 0 (this device) | K123359 | OVS1 Video System | Olive Medical Corp. | 2012 | — |
| +1 | K152513 | 8X-10-XXXX Camera System | Santa Barbara Imaging Systems | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 FCW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K070716 | Image 1 Video Imaging System with Optional Insufflators ControlSummary page 1…Not known Karl Storz Endoscopy- America, Inc Image I Video Imaging System With Option K070716 Karl Storz Endoscopy- America, Inc InnerVue Diagnostic Scope System K072879… | 2007 |
| * | K072879 | Innervue Diagnostic Scope SystemSummary page 1…ging System With Option K070716 Karl Storz Endoscopy- America, Inc InnerVue Diagnostic Scope System K072879 Biomet Sports Medicine Flexible Video Endoscope with Sheath and Video Processor K 102733 Vision-Scie… | 2008 |
| * | K102733 | Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Summary page 1…Vue Diagnostic Scope System K072879 Biomet Sports Medicine Flexible Video Endoscope with Sheath and Video Processor K 102733 Vision-Sciences, Inc LED Light Source K093792 Sunoptic Techn… | 2011 |
| * | K093792 | Led Light SourceSummary page 1…xible Video Endoscope with Sheath and Video Processor K 102733 Vision-Sciences, Inc LED Light Source K093792 Sunoptic Technologies, Inc. Device Description: The OVS I Video System is aCamera Control Unit with integrated LED Li… | 2010 |
| * | K961074 | Lightsource or IlluminatorSummary page 2…nologies, Inc. K093792 Lightsource or Illuminator N/A N/A N/A N/A Sunoptic Technologies, Inc. K961074 _______________________ *Output resolution unknown. Vertical lines of input listed… | 1996 |
| * | — | Tele Pack X Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152513 | 8X-10-XXXX Camera System | 2015 | 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?
- The line of descent spans 29 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- 6 of the 61 ancestors have a recall of any class.
- Of its descendants, K152513 (Santa Barbara Imaging Systems, 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K070716.
How does its category compare?
All FCW devicesFCW Light Source, Fiberoptic, Routine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · FCW
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FCW
Too few FCW 510(k)s in any year since 2007 to give a median.
Recalls per year · FCW
4in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCW
140in 2025
MAUDE reports naming product code FCW, 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 | 3 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 148 |
| 2010 | 1 | — | 0 | 713 |
| 2011 | 0 | — | 4 | 603 |
| 2012 | 2 | — | 0 | 77 |
| 2013 | 1 | — | 0 | 29 |
| 2014 | 1 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 24 |
| 2016 | 0 | — | 0 | 29 |
| 2017 | 0 | — | 0 | 59 |
| 2018 | 0 | — | 0 | 76 |
| 2019 | 0 | — | 0 | 118 |
| 2020 | 0 | — | 0 | 152 |
| 2021 | 0 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 166 |
| 2023 | 0 | — | 0 | 179 |
| 2024 | 0 | — | 0 | 179 |
| 2025 | 0 | — | 0 | 140 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OVS 1 Video System is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The OVS 1 Video System is indicated for use with a compatible Olive Medical Camera Head and other accessory devices including an endoscope, optical coupler, and light cable
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123359 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123359: OVS1 Video System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123359
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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