Boston Medical Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Boston Medical Corp.” (first 1989, latest 1999), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 38 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 7 | 7 |
| KGO | Surgeon'S Gloves | 1 | 1 |
Review panels
- General Hospital (8)
Most recent Boston Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981947 | STERILE POWDER FREE NITRILE SURGEONS GLOVES (NATURAL, BLUE AND GREEN) | KGO | 1999-03-03 | 273 |
| K960841 | POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM | LYY | 1996-08-15 | 170 |
| K923385 | BOSTON BRAND HYPOALLERGENIC LATEX GLOVES | LYY | 1992-10-15 | 100 |
| K911146 | TAN CHONG GLOVE, HYPOALLERGENIC | LYY | 1991-04-18 | 42 |
| K910660 | BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC | LYY | 1991-03-07 | 21 |
| K904232 | BOSTON(R) BRAND LATEX EXAM GLOVES/HYPOALLERGENIC | LYY | 1990-09-21 | 9 |
| K891103 | STERILE PATIENT EXAMINATION GLOVE | LYY | 1989-03-14 | 25 |
| K890538 | GUARDS LATEX & SAFE-CONTACT EXAMINATION GLOVES | LYY | 1989-03-10 | 35 |
Recalls
openFDA lists no recalls under a recalling firm named Boston Medical 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Boston Scientific Corp (730 510(k)s)
- Boston Scientific Scimed, Inc. (35 510(k)s)
- Boston Medical Products, Inc. (33 510(k)s)
- Boston Scientific, Target (19 510(k)s)
- Boston Surgical Products, Inc. (17 510(k)s)
- Boston Biomedica, Inc. (12 510(k)s)
- Boston Pacific Medical, Inc. (11 510(k)s)
- Boston Scientific Neuromodulation (10 510(k)s)
- Boston Aesthetics, Inc. (6 510(k)s)
- Boston Scientific /International Technologies (5 510(k)s)
- Boston Scientific/Medi-Tech (5 510(k)s)
- Boston Brace Intl., Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Boston Medical Corp.?
FDA lists 8 510(k) clearances under the applicant name “Boston Medical Corp.” (first 1989, latest 1999), across 2 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 Boston Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Boston Medical Corp. is 38 days.
Which FDA product codes appear under Boston Medical Corp.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 7); KGO (Surgeon'S Gloves, 1).
Next steps
- See all 8 Boston Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Boston Medical 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, 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.