Omniguide, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Omniguide, Inc.” (first 2006, latest 2021), across 1 product code in 1 review panel. Median 510(k) review time under this name: 34 days. Since 2017 the median was 73 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 223 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 73 |
| 2019 | 1 | 164 |
| 2020 | 0 | — |
| 2021 | 1 | 72 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Omniguide, Inc. took a median 73 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 14 | 14 |
Review panels
Most recent Omniguide, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203241 | OmniGuide BeamPath OTO-U Fiber | GEX | 2021-01-14 | 72 |
| K183199 | TRIO Handpiece | GEX | 2019-05-02 | 164 |
| K180993 | Beacon Advanced CO2 Laser System | GEX | 2018-06-28 | 73 |
| K140378 | FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT | GEX | 2014-09-25 | 223 |
| K093451 | OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP | GEX | 2009-11-20 | 15 |
| K093251 | OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM | GEX | 2009-10-29 | 13 |
| K081939 | OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY | GEX | 2008-08-12 | 35 |
| K073313 | MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP | GEX | 2008-01-02 | 37 |
| K073409 | OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM | GEX | 2007-12-14 | 10 |
| K070157 | OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER | GEX | 2007-02-01 | 15 |
4 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2012-11-05.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Omniguide Communications, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Omniguide, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Omniguide, Inc.” (first 2006, latest 2021), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Omniguide, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omniguide, Inc. is 34 days. Since 2017: 73 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Omniguide, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 14).
Next steps
- See all 14 Omniguide, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Omniguide, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.