Futuremed Div. of Future Impex Corp.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Futuremed Div. of Future Impex Corp.” (first 1985, latest 1994), across 10 product codes in 6 review panels. Median 510(k) review time under this name: 72 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | 4 | 4 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 3 | 3 |
| EWO | Audiometer | 2 | 2 |
| GYB | Media, Electroconductive | 2 | 2 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 1 | 1 |
| BZM | Calculator, Pulmonary Function Interpretor (Diagnostic) | 1 | 1 |
| DPS | Electrocardiograph | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| KGO | Surgeon'S Gloves | 1 | 1 |
Review panels
- Anesthesiology (6)
- Neurology (6)
- Ear, Nose and Throat (2)
- Cardiovascular (1)
- General Hospital (1)
- Physical Medicine (1)
Most recent Futuremed Div. of Future Impex Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933511 | UPGRADED SPIROMETER ST-90 | BTY | 1994-02-10 | 210 |
| K933220 | SELECTOR SL 01 | EWO | 1993-11-24 | 146 |
| K933222 | AUDIOMETER DA 323 | EWO | 1993-11-01 | 123 |
| K903017 | MEGA-TENS DUAL CHANNEL T.E.N.S. | GZJ | 1990-10-26 | 108 |
| K901308 | SPIRO ANALYZER MODEL ST 250 | BZG | 1990-07-23 | 125 |
| K884972 | TRANSCOUTANEOUS ELECTRO-NEURO STIMULATOR | GZJ | 1989-07-27 | 239 |
| K871421 | MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT | IPF | 1988-01-22 | 288 |
| K873817 | SPIRO ANALYZER ST-300 | BZG | 1987-12-02 | 72 |
| K872044 | CARBON ELECTRODE | GXY | 1987-07-16 | 50 |
| K872045 | CONDUCTIVITY GEL | GYB | 1987-07-15 | 49 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Futuremed Div. of Future Impex 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.
- Futuremed America, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Futuremed Div. of Future Impex Corp.?
FDA lists 17 510(k) clearances under the applicant name “Futuremed Div. of Future Impex Corp.” (first 1985, latest 1994), across 10 product codes in 6 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 Futuremed Div. of Future Impex Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Futuremed Div. of Future Impex Corp. is 72 days.
Which FDA product codes appear under Futuremed Div. of Future Impex Corp.?
The most frequent FDA product codes under this applicant name are BZG (Spirometer, Diagnostic, 4); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 3); EWO (Audiometer, 2).
Next steps
- See all 17 Futuremed Div. of Future Impex Corp. clearances with predicates and recalls
- Run predicate analysis for product code BZG, Futuremed Div. of Future Impex 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.