Bloomex International, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Bloomex International, Inc.” (first 1979, latest 1995), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 14 | 14 |
| LEJ | Booth, Sun Tan | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Bloomex International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943185 | BX-200 SC | IPF | 1995-08-14 | 489 |
| K942195 | BX-400S | IPF | 1995-08-14 | 489 |
| K842142 | BX-400 | IPF | 1984-06-25 | 26 |
| K841779 | ELECTRONIC MUSCLE EXERCISE EQUIPMENT | IPF | 1984-05-30 | 30 |
| K832976 | BX-600 EMS | IPF | 1983-11-25 | 84 |
| K822287 | BX-500 ELECTRONIC MUSCLE EXERCISER | IPF | 1982-10-13 | 75 |
| K821110 | ELECTRONIC MUSCLE EXERCISER | IPF | 1982-07-01 | 72 |
| K820080 | BX-1000 ISOMATIC | IPF | 1982-07-01 | 170 |
| K813443 | BX-400 SPORT | IPF | 1982-03-08 | 89 |
| K813410 | BX-400 JESSE JIMBODY | IPF | 1982-03-08 | 94 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bloomex 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bloomex International, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Bloomex International, Inc.” (first 1979, latest 1995), across 3 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 Bloomex International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bloomex International, Inc. is 80 days.
Which FDA product codes appear under Bloomex International, Inc.?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 14); LEJ (Booth, Sun Tan, 1).
Next steps
- See all 16 Bloomex International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Bloomex 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.