510(k) · Cleared
Recalled · 2005DR. FOG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O.R. Concepts, Inc. · OCT Anti Fog Solution And Accessories, Endoscopy
Cleared on Aug 11, 1993 after an 83-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 11, 1993
- Review
- 83 days
- Class
- Class II
- Product code
- OCT
- Recalls
- 2
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK932449 DR. FOGO.R. Concepts, Inc. · 1993
- Descendant · cites it directly · 0 of its ownK231822 GOLFF Sterile Anti-Fog SolutionBatrik Medical Manufacturing, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK190864 Konix Anti-Fog SolutionTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K932449 | DR. FOG | O.R. Concepts, Inc. | 1993 | — |
| +1 | K231822 | GOLFF Sterile Anti-Fog Solution | Batrik Medical Manufacturing, Inc. | 2024 | — |
| +1 | K190864 | Konix Anti-Fog Solution | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (2)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 15, 2005 | Not classified | Z-0897-05 | Process control | An improper expiration date was placed on the individual packages, although the dispenser box and carton contained the correct expiration date. |
| Apr 30, 2003 | Not classified | Z-0828-03 | Packaging process control | Sterility compromised - incomplete sterile package seal. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K231822 (Batrik Medical Manufacturing, Inc., 2024) has gone furthest, with 0 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K932449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K932449: DR. FOG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932449
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026