510(k) · Cleared
ClearedKonix Anti-Fog Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler · OCT Anti Fog Solution And Accessories, Endoscopy
Cleared on Aug 27, 2020 as substantially equivalent to K932449 (O.R. Concepts, Inc., 1993) after a 512-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Aug 27, 2020
- Review
- 512 days
- Class
- Class II
- Product code
- OCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932449 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK932449 DR. FOGO.R. Concepts, Inc. · 1993 · Recalled
- This deviceK190864 Konix Anti-Fog SolutionTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932449 | DR. FOG | O.R. Concepts, Inc. | 1993 | 2 |
| 0 (this device) | K190864 | Konix Anti-Fog Solution | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler | 2020 | — |
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 |
|---|---|---|---|
| * | K932449 | DR. FOGSummary page 4…ion Panel: Gastroenterology/Urology Product Code: OCT III. PREDICATE DEVICE Trade/Device Name: Dr Fog Common or Usual Name Endoscope Anti-fogging Device 510(k) Number K932449 Regulation Name and Number: Endoscope and accessories (21 CFR 876.1500) Product Code: OCT Submitter: O.R Concepts, INC. Submitter… | 1993 |
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?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K932449.
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. 2020, 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?
KONIX Anti-Fog solution is a sterile, disposable, functional, anti-fog solution. The antifog solution is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens. KONIX Antifog Solution is used to prevent the lenses of the imaging device from fogging due to the difference in body temperature before and during endoscopic and laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190864 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190864: Konix 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/K190864
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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