510(k) · Cleared
ClearedVitreOx Anti-fog Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sio2 Nanotech, LLC · OCT Anti Fog Solution And Accessories, Endoscopy
Cleared on May 24, 2017 as substantially equivalent to K062779 (New Wave Surgical Corporation, 2006) after a 191-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- May 24, 2017
- Review
- 191 days
- Class
- Class II
- Product code
- OCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K904871 (1991). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK904871 Medi-KleerNorth American Marketing Corp. · 1991
- 2 generations backK974454 Clearfield Anti-Fog Sterile Wipe, Product Number 300-004Tucson Medical Corp. · 1997
- 1 generation backK062779 Defogging Heated Endoscope Lens Protector (Dhelp); Defogging…New Wave Surgical Corporation · 2006 · Recalled
- This deviceK163257 VitreOx Anti-fog SolutionSio2 Nanotech, LLC · 2017
- Descendant · cites it directly · 0 of its ownK251068 KnoxFog Anti-fogging DeviceUv One Hygienics, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251068KnoxFog Anti-fogging DeviceUv One Hygienics, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904871 | Medi-Kleer | North American Marketing Corp. | 1991 | — |
| −2 | K974454 | Clearfield Anti-Fog Sterile Wipe, Product Number 300-004 | Tucson Medical Corp. | 1997 | — |
| −1 | K062779 | Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens… | New Wave Surgical Corporation | 2006 | 2 |
| 0 (this device) | K163257 | VitreOx Anti-fog Solution | Sio2 Nanotech, LLC | 2017 | — |
| +1 | K251068 | KnoxFog Anti-fogging Device | Uv One Hygienics, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 OCT? 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 OCT device
- #1 K251068 KnoxFog Anti-fogging Devicescore 10.8 · 4 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 |
|---|---|---|---|
| * | K062779 | Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector…Summary page 4…marketed devices to which we are claiming equivalence The different components of the VitreOx® device are functionally equivalent to the following supplies and devices: K062779 Defogging Endoscope Lens Protector. Substantial Equivalence: The different components of the VitreOx® device are functionally eq… | 2006 |
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 |
|---|---|---|---|
| K251068 | KnoxFog Anti-fogging Device | 2025 | 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 26 years and passes through 4 companies; a new generation was cleared every 8.8 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K251068 (Uv One Hygienics, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K062779.
How does its category compare?
All OCT devicesOCT Anti Fog Solution And Accessories, Endoscopy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OCT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCT
Too few OCT 510(k)s in any year since 2007 to give a median.
Recalls per year · OCT
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCT
13in 2025
MAUDE reports naming product code OCT, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 1 | — | 0 | 27 |
| 2017 | 1 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 20 |
| 2019 | 1 | — | 0 | 20 |
| 2020 | 1 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 16 |
| 2022 | 1 | — | 1 | 10 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
VitreOx® is a temporary anti-fog coating and therein defogs devices such as a laparoscopic accessory intended to facilitate intraoperative defogging of the laparoscope lens thereby maintaining visualization of the surgical site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163257 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163257: VitreOx Anti-fog Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163257
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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