510(k) · Cleared
ClearedGOLFF Sterile Anti-Fog Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Batrik Medical Manufacturing, Inc. · OCT Anti Fog Solution And Accessories, Endoscopy
Cleared on Feb 26, 2024 as substantially equivalent to K932449 (O.R. Concepts, Inc., 1993) and 1 other predicate after a 250-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Feb 26, 2024
- Review
- 250 days
- Class
- Class II
- Product code
- OCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932449 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK932449 DR. FOGO.R. Concepts, Inc. · 1993 · Recalled
- This deviceK231822 GOLFF Sterile Anti-Fog SolutionBatrik Medical Manufacturing, Inc. · 2024
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) | K231822 | GOLFF Sterile Anti-Fog Solution | Batrik Medical Manufacturing, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (2)
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 5…t Code: OCT 3. Substantial Equivalence: Legally marketed devices with equivalence are claimed: • Primary Predicate: Aspen Surgical Inc. Dr. Fog:510(k) K932449 • Secondary Predicate: Medline Anti-Fog Solution 510(k) Kl 52948 4. Device Description: GOLFF Sterile Anti-Fog Solution is us… | 1993 |
| * | K152948 | Medline Anti-Fog SolutionSummary page 5…s similar in intended use, handling and technology compared to the device described in this submission. b. Secondary Predicate: Medline Anti-Fog Solution 510(k) K152948 dated 04-FEB-2016 is similar in intended use,… | 2016 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 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. 2024, 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?
The GOLFF Sterile Anti-Fog Solution is a single-use, medical device, anti-fog solution used by hospital staff to apply on
lenses of endoscopic and laparoscopic cameras. The solution is provided in an easy-to-squeeze bottle and comes with an
adhesive-backed sponge for secure placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231822 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231822: GOLFF Sterile 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/K231822
Report an extraction error
Are you the manufacturer?
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