Omni Intl., Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Omni Intl., Inc.” (first 1982, latest 1999), across 9 product codes in 7 review panels. Median 510(k) review time under this name: 43 days. 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 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 2 | 2 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 2 | 2 |
| KGO | Surgeon'S Gloves | 2 | 2 |
| CAT | Cannula, Nasal, Oxygen | 1 | 1 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| FIB | Protector, Transducer, Dialysis | 1 | 1 |
| FYA | Gown, Surgical | 1 | 1 |
| HXD | Clamp | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
Review panels
- General Hospital (5)
- Neurology (2)
- Anesthesiology (1)
- Dental (1)
- Gastroenterology and Urology (1)
- Physical Medicine (1)
- General and Plastic Surgery (1)
Most recent Omni Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K984066 | OMNIGRIP, LATEX SURGICAL GLOVE, POWDER-FREE WITH PROTEIN LABELING CLAIM | KGO | 1999-01-13 | 58 |
| K984064 | OMNIGRIP, LATEX SURGICAL GLOVE, POWDER FREE | KGO | 1999-01-08 | 53 |
| K853255 | OMNIMED I.V. SOLUTION ADMIN. SET | FPA | 1985-08-23 | 21 |
| K851938 | OMNIMED SURGICAL GOWN | FYA | 1985-06-28 | 56 |
| K851654 | OMNIMED CLAMP | HXD | 1985-05-31 | 39 |
| K851734 | OMNIMED SUPERIOR TRANSDUCER PROTECTOR | FIB | 1985-05-23 | 28 |
| K850706 | F-SERIES IMPLANT | DZE | 1985-04-10 | 47 |
| K850112 | OMNIMED IV SOLUTION ADMINISTRATION SET | FPA | 1985-02-22 | 39 |
| K850066 | OMNIMED NASAL OXYGEN CANNULA | CAT | 1985-01-24 | 16 |
| K831147 | OMNIPROBE ELECTRICAL NERVE STIMULATOR | GZJ | 1983-07-18 | 101 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Omni Intl., Inc..
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.
- Omni Life Science, Inc. (21 510(k)s)
- Omni Hearing Systems (7 510(k)s)
- Omni Therm, Inc. (5 510(k)s)
- Omni-Tract Surgical, Div. Minn. Scientific, Inc. (4 510(k)s)
- Omni-Guide Holdings, Inc. (2 510(k)s)
- Omni Sales Corp. (2 510(k)s)
- Omni Surgical, L.P. (2 510(k)s)
- Omni-Flow, Inc. (1 510(k)s)
- Omni-Glow, Inc. (1 510(k)s)
- Omni Medical Designs (1 510(k)s)
- Omni Mfg., Inc. (1 510(k)s)
- Omni Scientific, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Omni Intl., Inc.?
FDA lists 12 510(k) clearances under the applicant name “Omni Intl., Inc.” (first 1982, latest 1999), across 9 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Omni Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omni Intl., Inc. is 43 days.
Which FDA product codes appear under Omni Intl., Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 2); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 2); KGO (Surgeon'S Gloves, 2).
Next steps
- See all 12 Omni Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Omni Intl., 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.