Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Omniguide, Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
164 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|
| K203241 | OmniGuide BeamPath OTO-U Fiber | Omniguide, Inc. | 2021-01-14 | 72 | 0 |
| K183199 | TRIO Handpiece | Omniguide, Inc. | 2019-05-02 | 164 | 0 |
| K180993 | Beacon Advanced CO2 Laser System | Omniguide, Inc. | 2018-06-28 | 73 | 0 |
| K140378 | FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT | Omniguide, Inc. | 2014-09-25 | 223 | 0 |
| K093451 | OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PRO | Omniguide, Inc. | 2009-11-20 | 15 | 0 |
| K093251 | OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM | Omniguide, Inc. | 2009-10-29 | 13 | 0 |
| K081939 | OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZ | Omniguide, Inc. | 2008-08-12 | 35 | 0 |
| K073313 | MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP | Omniguide, Inc. | 2008-01-02 | 37 | 0 |
| K073409 | OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM | Omniguide, Inc. | 2007-12-14 | 10 | 0 |
| K070157 | OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER | Omniguide, Inc. | 2007-02-01 | 15 | 1 |
| K070071 | OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER | Omniguide, Inc. | 2007-01-25 | 17 | 0 |
| K063141 | OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER | Omniguide, Inc. | 2006-11-29 | 44 | 0 |
| K062423 | OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM | Omniguide, Inc. | 2006-09-21 | 34 | 0 |
| K061909 | HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00 | Omniguide, Inc. | 2006-07-19 | 13 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda