Std Mfg., Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Std Mfg., Inc.” (first 1993, latest 2003), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| GDW | Staple, Implantable | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 | 1 |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 1 | 1 |
Review panels
Most recent Std Mfg., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023096 | CONTOURED ARTICULAR PROSTHESIS (CAP) HUMERAL HEAD RESURFACING SYSTEM | HSD | 2003-04-10 | 204 |
| K021549 | CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM | KXA | 2002-08-01 | 80 |
| K012362 | MODIFICATION TO VASCULAR CLOSURE DEVICE | GDW | 2001-08-23 | 29 |
| K003169 | VASCULAR CLOSURE DEVICE | GDW | 2000-12-08 | 59 |
| K000608 | SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM | GDW | 2000-03-07 | 13 |
| K930427 | STD IRRIGATION PUMP | GCJ | 1993-06-01 | 126 |
Recalls
openFDA lists no recalls under a recalling firm named Std Mfg., 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 Std Mfg., Inc.?
FDA lists 6 510(k) clearances under the applicant name “Std Mfg., Inc.” (first 1993, latest 2003), across 4 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 Std Mfg., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Std Mfg., Inc. is 70 days.
Which FDA product codes appear under Std Mfg., Inc.?
The most frequent FDA product codes under this applicant name are GDW (Staple, Implantable, 3); GCJ (Laparoscope, General & Plastic Surgery, 1); HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, 1).
Next steps
- See all 6 Std Mfg., Inc. clearances with predicates and recalls
- Run predicate analysis for product code GDW, Std Mfg., 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.