Fortune Medical Instrument Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Fortune Medical Instrument Corp.” (first 1998, latest 2003), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 132 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 |
|---|---|---|---|
| EZL | Catheter, Retention Type, Balloon | 2 | 2 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 1 | 1 |
| HDB | Extractor, Vacuum, Fetal | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| KOB | Catheter, Suprapubic (And Accessories) | 1 | 1 |
Review panels
Most recent Fortune Medical Instrument Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022112 | FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020 | KNT | 2003-04-03 | 279 |
| K021193 | FORTUNE SILICONE VACUUM SUCTION, MODEL #1300 | HDB | 2003-02-12 | 303 |
| K021142 | ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 | EZL | 2002-10-01 | 175 |
| K014002 | ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890 | KOB | 2002-03-04 | 90 |
| K980917 | ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR | GCA | 1998-05-27 | 77 |
| K980919 | ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER | EZL | 1998-03-31 | 20 |
Recalls
openFDA lists no recalls under a recalling firm named Fortune Medical Instrument 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Fortune Medical Instrument Corp.?
FDA lists 6 510(k) clearances under the applicant name “Fortune Medical Instrument Corp.” (first 1998, latest 2003), across 5 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 Fortune Medical Instrument Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fortune Medical Instrument Corp. is 132 days.
Which FDA product codes appear under Fortune Medical Instrument Corp.?
The most frequent FDA product codes under this applicant name are EZL (Catheter, Retention Type, Balloon, 2); GCA (Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection, 1); HDB (Extractor, Vacuum, Fetal, 1).
Next steps
- See all 6 Fortune Medical Instrument Corp. clearances with predicates and recalls
- Run predicate analysis for product code EZL, Fortune Medical Instrument 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.