Best Medical International, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Best Medical International, Inc.” (first 2004, latest 2018), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 48 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 | 1 | 84 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 583 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Best Medical International, Inc. took a median 583 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 3 | 3 |
| KXK | Source, Brachytherapy, Radionuclide | 3 | 3 |
Review panels
- Radiology (6)
Most recent Best Medical International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162499 | Best Instruminal Applicator | JAQ | 2018-04-13 | 583 |
| K132097 | BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY | JAQ | 2013-09-30 | 84 |
| K061638 | BEST STRAND AND BEST SPACER | KXK | 2006-08-04 | 53 |
| K043117 | BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER | KXK | 2004-12-09 | 29 |
| K042786 | BEST MODEL # 81-01 SERIES IR-192 SOURCES | KXK | 2004-11-18 | 43 |
| K042586 | BEST BREAST BRACHYTHERAPY APPLICATOR | JAQ | 2004-11-03 | 42 |
Recalls
openFDA lists no recalls under a recalling firm named Best Medical International, 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.
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.
- Best Industries (9 510(k)s)
- Best Manufacturing Company (6 510(k)s)
- Best Nomos (5 510(k)s)
- Best Labs (4 510(k)s)
- Best Putra Gloves Sdn Bhd (4 510(k)s)
- Best Theratronics Limited (4 510(k)s)
- Best Assoc. Corp. (2 510(k)s)
- Best Glove, Inc. (2 510(k)s)
- Best Sanitizers, Inc. (2 510(k)s)
- Best Aid, Inc. (1 510(k)s)
- Best Care Trading Co., Ltd. (1 510(k)s)
- Best Manufacturing Company-Distribution Center (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Best Medical International, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Best Medical International, Inc.” (first 2004, latest 2018), 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 Best Medical International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Best Medical International, Inc. is 48 days.
Which FDA product codes appear under Best Medical International, Inc.?
The most frequent FDA product codes under this applicant name are JAQ (System, Applicator, Radionuclide, Remote-Controlled, 3); KXK (Source, Brachytherapy, Radionuclide, 3).
Next steps
- See all 6 Best Medical International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAQ, Best Medical International, 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.