Omni Therm, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Omni Therm, Inc.” (first 1987, latest 1996), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 112 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 |
|---|---|---|---|
| IMD | Pack, Hot Or Cold, Disposable | 4 | 4 |
| KPD | Strip, Temperature, Forehead, Liquid Crystal | 1 | 1 |
Review panels
Most recent Omni Therm, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961176 | OMNI COLD GEL PACKS | IMD | 1996-09-04 | 163 |
| K955788 | IMNI HOT PACKS | IMD | 1996-09-04 | 257 |
| K954877 | OMNI COLD GEL PACKS | IMD | 1996-02-13 | 112 |
| K936084 | OMNI WARM GEL PACKS | IMD | 1994-03-31 | 100 |
| K864853 | OMNI THERM TEMPERATURE MONITOR | KPD | 1987-02-04 | 55 |
Recalls
openFDA lists no recalls under a recalling firm named Omni Therm, 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 Intl., Inc. (12 510(k)s)
- Omni Hearing Systems (7 510(k)s)
- Omni Sales Corp. (2 510(k)s)
- Omni Surgical, L.P. (2 510(k)s)
- Omni Medical Designs (1 510(k)s)
- Omni Mfg., Inc. (1 510(k)s)
- Omni Scientific, Inc. (1 510(k)s)
- Omni Surgical, LLC Dba Spine360 (1 510(k)s)
- Omni Surgical, LP Dba Spine360 (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Omni Therm, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Omni Therm, Inc.” (first 1987, latest 1996), across 2 product codes in 2 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 Therm, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omni Therm, Inc. is 112 days.
Which FDA product codes appear under Omni Therm, Inc.?
The most frequent FDA product codes under this applicant name are IMD (Pack, Hot Or Cold, Disposable, 4); KPD (Strip, Temperature, Forehead, Liquid Crystal, 1).
Next steps
- See all 5 Omni Therm, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IMD, Omni Therm, 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.