U.S. Medical Products, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “U.S. Medical Products, Inc.” (first 1992, latest 1996), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 106 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 |
|---|---|---|---|
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 7 | 7 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 5 | 5 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 5 | 5 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 4 | 4 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 1 | 1 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 1 | 1 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 1 | 1 |
Review panels
- Orthopedic (24)
Most recent U.S. Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962215 | CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTER | HWE | 1996-08-15 | 66 |
| K954818 | CONSENSUS POSTERIOR STABILIZED KNEE | JWH | 1996-05-22 | 215 |
| K953443 | CONSENSUS PCL SUBSITUTING TIBIAL INSERT | JWH | 1996-04-26 | 284 |
| K960302 | CONSENSUS ACETABULAR SHELL, ALL UHMWPE | JDI | 1996-04-01 | 70 |
| K952943 | CONSENSUS ALL POLY TIBIA | JWH | 1996-04-01 | 280 |
| K960340 | CONSENSUS APEX DOME HOLE PLUG | JDI | 1996-03-15 | 51 |
| K960339 | CONSENSUS 22MM COCRMO FEMORAL HEAD | JDI | 1996-02-21 | 28 |
| K960156 | CONSENSUS 32MM COCRMO FEMORAL HEAD | JDI | 1996-02-21 | 41 |
| K960151 | CONSENSUS 26MM COCRMO FEMORAL HEAD | JDI | 1996-02-21 | 41 |
| K955386 | CONSENSUS ZIRCONIA FEMORAL HEAD | LZO | 1996-02-20 | 90 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named U.S. Medical Products, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under U.S. Medical Products, Inc.?
FDA lists 24 510(k) clearances under the applicant name “U.S. Medical Products, Inc.” (first 1992, latest 1996), across 7 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 U.S. Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name U.S. Medical Products, Inc. is 106 days.
Which FDA product codes appear under U.S. Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment, 7); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 5); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 5).
Next steps
- See all 24 U.S. Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HWE, U.S. Medical Products, 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.