Allo Pro Corp.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Allo Pro Corp.” (first 1981, latest 1990), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 89 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 4 | 4 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 3 | 3 |
| LZN | Cement Obturator | 2 | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 2 | 2 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | 1 | 1 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 1 | 1 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 1 | 1 |
| LYU | Accessory, Surgical Apparel | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (14)
- General Hospital (1)
Most recent Allo Pro Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K901581 | GSB ELBOW | JDC | 1990-10-22 | 201 |
| K900425 | SURGICAL COTTON GLOVES | LYU | 1990-09-07 | 220 |
| K900392 | CENTERING PLUG | LZN | 1990-03-01 | 34 |
| K896669 | WEBER PERMALOCK | LZO | 1990-02-06 | 71 |
| K892644 | BIOLOX CERAMIC BALL | LZO | 1989-10-19 | 190 |
| K885049 | RS-CUP ACETABULAR PROSTHESIS | KWA | 1989-01-13 | 37 |
| K864999 | KENNEDY STEM | JDI | 1987-09-09 | 261 |
| K871453 | ZWEYMUELLER-SL HIP PROSTHESIS STEM | KWA | 1987-07-13 | 91 |
| K851213 | ZWEYMULLER CUP | KWA | 1985-05-28 | 63 |
| K841391 | WEBER-STUHMER HIP PROSTHESIS STEM | JDI | 1984-04-13 | 10 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Allo Pro Corp..
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 Allo Pro Corp.?
FDA lists 16 510(k) clearances under the applicant name “Allo Pro Corp.” (first 1981, latest 1990), across 9 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 Allo Pro Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Allo Pro Corp. is 89 days.
Which FDA product codes appear under Allo Pro Corp.?
The most frequent FDA product codes under this applicant name are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 4); KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), 3); LZN (Cement Obturator, 2).
Next steps
- See all 16 Allo Pro Corp. clearances with predicates and recalls
- Run predicate analysis for product code JDI, Allo Pro Corp.'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.