Omni Life Science, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Omni Life Science, Inc.” (first 2006, latest 2019), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 86 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 | 2 | 108 |
| 2013 | 1 | 139 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 160 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 86 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 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 Omni Life Science, Inc. took a median 86 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 8 | 8 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 7 | 7 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 4 | 4 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 1 | 1 |
Review panels
- Orthopedic (21)
Most recent Omni Life Science, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191765 | OMNI TiN Coated Apex Knee System | JWH | 2019-09-25 | 86 |
| K152919 | OMNI Skirted Heads | LZO | 2016-03-10 | 160 |
| K131472 | APEX KNEE MODULAR TIBIA SYSTEM | JWH | 2013-10-08 | 139 |
| K112891 | APEX REVISION KNEE SYSTEMS | JWH | 2012-02-29 | 152 |
| K113242 | APEX ARC HIP STEM | LPH | 2012-01-05 | 64 |
| K111062 | APEX KNEE SYSTEM, APEX ALL POLY TIBIA | JWH | 2011-07-13 | 86 |
| K111193 | APEX ARC HIP STEM | LZO | 2011-06-27 | 60 |
| K111184 | APEX PS KNEE SYSTEM - PS-C INSERT | JWH | 2011-06-22 | 56 |
| K110947 | APEX K1 HIP STEM | LPH | 2011-06-16 | 73 |
| K102578 | APEX PS KNEE SYSTEM | JWH | 2011-03-25 | 198 |
11 earlier clearances. See the full list in Caduvo.
Recalls
30 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2016-10-14.
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 Intl., Inc. (12 510(k)s)
- Omni Hearing Systems (7 510(k)s)
- Omni Therm, Inc. (5 510(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 Life Science, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Omni Life Science, Inc.” (first 2006, latest 2019), across 5 product codes 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 Omni Life Science, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omni Life Science, Inc. is 86 days.
Which FDA product codes appear under Omni Life Science, Inc.?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 8); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 7); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 4).
Next steps
- See all 21 Omni Life Science, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Omni Life Science, 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.