Future Impex Corp.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Future Impex Corp.” (first 1983, latest 1986), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 71 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 | 5 | 5 |
| GKL | Counter, Cell, Automated (Particle Counter) | 2 | 2 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 1 | 1 |
| DPS | Electrocardiograph | 1 | 1 |
| GKM | Hand-Tally, Differential | 1 | 1 |
| JBP | Activated Whole Blood Clotting Time | 1 | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | 1 |
| KHG | Whole Blood Hemoglobin Determination | 1 | 1 |
Plus 1 more product codes.
Review panels
- Anesthesiology (6)
- Hematology (5)
- Clinical Chemistry (1)
- Cardiovascular (1)
Most recent Future Impex Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861487 | ST-90 SPIRO ANALIZER | BTY | 1986-06-23 | 73 |
| K854687 | ERMA HB-METER MODEL 303N | KHG | 1986-06-04 | 196 |
| K854686 | TE-25 COAGURO METER | JBP | 1986-06-04 | 196 |
| K854685 | DIGITAL-9 KEY LEUCOCYTE COUNTER | GKM | 1986-04-04 | 135 |
| K854678 | ERMA PC-602 PC-603 BLOOD CELL COUNTER | GKL | 1986-02-24 | 81 |
| K854677 | ERMA PC-604 BLOOD CELL COUNTER | GKL | 1986-02-24 | 96 |
| K854679 | PHOTIC-100 SPECTROPHOTOMETER | JJQ | 1986-02-20 | 92 |
| K843934 | MODEL {M-102 I-CHANNEL ELECTRO CARDIOGRAPH UNIT | DPS | 1984-11-20 | 42 |
| K843984 | PM-80 PULMOTESTER | BZG | 1984-10-24 | 13 |
| K843700 | ST-200A W/MAXIMAL VOLUNTARY VENTILLAT- | — | 1984-10-24 | 34 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named 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.
- Future Medical Systems, Inc. (12 510(k)s)
- Future Mobility Healthcare, Inc. (5 510(k)s)
- Future Diagnostics B.V. (2 510(k)s)
- Future Medical Systems, SA (2 510(k)s)
- Future Device and Technology, Inc. (1 510(k)s)
- Future Medical Products, Inc. (1 510(k)s)
- Future Medical Technologies Intl., Inc. (1 510(k)s)
- Future Path Medical, LLC (1 510(k)s)
- Future Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Future Impex Corp.?
FDA lists 14 510(k) clearances under the applicant name “Future Impex Corp.” (first 1983, latest 1986), across 9 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 Future Impex Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Future Impex Corp. is 71 days.
Which FDA product codes appear under Future Impex Corp.?
The most frequent FDA product codes under this applicant name are BZG (Spirometer, Diagnostic, 5); GKL (Counter, Cell, Automated (Particle Counter), 2); BTY (Calculator, Predicted Values, Pulmonary Function, 1).
Next steps
- See all 14 Future Impex Corp. clearances with predicates and recalls
- Run predicate analysis for product code BZG, 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.