Oxboro Medical Intl., Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Oxboro Medical Intl., Inc.” (first 1988, latest 1996), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 77 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 |
|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 2 | 2 |
| FPX | Strip, Adhesive, Closure, Skin | 1 | 1 |
| GDX | Scalpel, One-Piece | 1 | 1 |
| HQP | Unit, Cautery, Thermal, Battery-Powered | 1 | 1 |
| LRN | Wire, Surgical | 1 | 1 |
Review panels
- General Hospital (2)
- General and Plastic Surgery (2)
- Ophthalmic (1)
- Orthopedic (1)
Most recent Oxboro Medical Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K953068 | OXBORO-MEDICAL FOAM INSTRUMENT HOLDER | KCT | 1996-01-23 | 207 |
| K952787 | FOAM INSTRUMENT GUARD | KCT | 1995-12-28 | 192 |
| K952783 | OXBORO-MEDICAL PIN COVERS | LRN | 1995-09-15 | 88 |
| K952784 | OXBORO-MEDICAL CAUTERY TIP CLEANER | HQP | 1995-07-13 | 24 |
| K880028 | OMED DISPOSABLE SCALPEL | GDX | 1988-01-29 | 24 |
| K874813 | OMED WOUND CLOSURE STRIPS | FPX | 1988-01-29 | 66 |
Recalls
openFDA lists no recalls under a recalling firm named Oxboro Medical Intl., 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 Oxboro Medical Intl., Inc.?
FDA lists 6 510(k) clearances under the applicant name “Oxboro Medical Intl., Inc.” (first 1988, latest 1996), across 5 product codes in 4 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 Oxboro Medical Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oxboro Medical Intl., Inc. is 77 days.
Which FDA product codes appear under Oxboro Medical Intl., Inc.?
The most frequent FDA product codes under this applicant name are KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 2); FPX (Strip, Adhesive, Closure, Skin, 1); GDX (Scalpel, One-Piece, 1).
Next steps
- See all 6 Oxboro Medical Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code KCT, Oxboro Medical Intl., 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.