FDA product code OCT: Anti Fog Solution And Accessories, Endoscopy
OCT is the FDA product code for anti fog solution and accessories, endoscopy. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 27 510(k) submissions under OCT, 3 in the last five years, from 26 different applicants. The average 510(k) review took 163 days (median 128); 196 days on average over the last three years. FDA has posted 2 recalls for OCT devices, 1 initiated in the last five years.
Definition
To prevent, reduce or eliminate condensation (fog) on endoscopic lens.
Classification
| Field | Value |
|---|---|
| Device name | Anti Fog Solution And Accessories, Endoscopy |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OCT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 191 |
| 2019 | 1 | 193 |
| 2020 | 1 | 512 |
| 2022 | 1 | 64 |
| 2024 | 1 | 250 |
| 2025 | 1 | 142 |
Compare with all 510(k) review times · Search every OCT clearance
Top OCT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Minimally Invasive Devices, LLC | 2 | 2010-12-23 |
| Uv One Hygienics, Inc. | 1 | 2025-08-27 |
| Batrik Medical Manufacturing, Inc. | 1 | 2024-02-26 |
| Jdi Surgical, Inc. | 1 | 2022-07-07 |
| Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler | 1 | 2020-08-27 |
21 more applicants have OCT clearances. See the full list in Caduvo.
Most recent OCT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251068 | Uv One Hygienics, Inc. | KnoxFog Anti-fogging Device | 2025-08-27 | 142 |
| K231822 | Batrik Medical Manufacturing, Inc. | GOLFF Sterile Anti-Fog Solution | 2024-02-26 | 250 |
| K221293 | Jdi Surgical, Inc. | E-Brik Visualization Assistant | 2022-07-07 | 64 |
| K190864 | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler | Konix Anti-Fog Solution | 2020-08-27 | 512 |
| K181887 | Advanced Medical Design Co., Ltd. | AMD Anti-Fog Solution | 2019-01-22 | 193 |
Recalls for OCT devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-01-14.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code OCT?
OCT is the FDA product code for anti fog solution and accessories, endoscopy. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is OCT?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code OCT?
Across 27 cleared submissions the average was 163 days from receipt to decision (median 128).
Which companies have the most OCT clearances?
Minimally Invasive Devices, LLC (2); Uv One Hygienics, Inc. (1); Batrik Medical Manufacturing, Inc. (1); Jdi Surgical, Inc. (1); Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler (1).
Have OCT devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-01-14.
Next steps
- Run an FDA pathway report with predicate devices for product code OCT
- Run a recall and safety report across every OCT manufacturer
- Watch product code OCT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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