Omnlife Science: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Omnlife Science” (first 2008, latest 2015), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 71 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 | 1 | 168 |
| 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 |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 3 | 3 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 2 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
Review panels
- Orthopedic (6)
Most recent Omnlife Science 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142201 | OMNI Interface Acetabular System | LPH | 2015-01-26 | 168 |
| K112779 | APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM) | LPH | 2011-12-02 | 67 |
| K101994 | APEX KNEE MODULAR TIBIA SYSTEM | JWH | 2010-09-28 | 75 |
| K101575 | APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010 | LPH | 2010-06-30 | 23 |
| K100151 | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM) | KWY | 2010-05-28 | 129 |
| K073602 | MODIFICATION TO: APEX KNEE SYSTEM | JWH | 2008-02-14 | 55 |
Recalls
openFDA lists no recalls under a recalling firm named Omnlife Science.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Omnlife Science?
FDA lists 6 510(k) clearances under the applicant name “Omnlife Science” (first 2008, latest 2015), across 3 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 Omnlife Science?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omnlife Science is 71 days.
Which FDA product codes appear under Omnlife Science?
The most frequent FDA product codes under this applicant name are LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 3); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 2); KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, 1).
Next steps
- See all 6 Omnlife Science clearances with predicates and recalls
- Run predicate analysis for product code LPH, Omnlife Science'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.