Seven Harvest Intl. Import & Export: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Seven Harvest Intl. Import & Export” (first 1981, latest 1994), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 35 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 |
|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | 2 | 2 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
| BYG | Mask, Oxygen | 1 | 1 |
| BZA | Connector, Airway (Extension) | 1 | 1 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 | 1 |
| CAT | Cannula, Nasal, Oxygen | 1 | 1 |
Review panels
- Anesthesiology (7)
Most recent Seven Harvest Intl. Import & Export 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940793 | DOUBLE TRACH SWIVEL CONNECTOR | BZA | 1994-07-01 | 129 |
| K823506 | NASAL CANNULA | CAT | 1982-12-09 | 15 |
| K823143 | BUBBLE HUMIDIFIERS | BTT | 1982-11-29 | 35 |
| K823142 | OXYGEN TUBINGS | BYX | 1982-11-29 | 35 |
| K823141 | OXYGEN MASKS | BYG | 1982-11-29 | 35 |
| K820709 | AIRWAYS | CAE | 1982-06-25 | 99 |
| K813074 | CONNECTORS & ADAPTERS | BYX | 1981-12-31 | 59 |
Recalls
openFDA lists no recalls under a recalling firm named Seven Harvest Intl. Import & Export.
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.
- Seven C'S, Inc. (1 510(k)s)
- Seven Oaks Ranch, Inc. (1 510(k)s)
- Seven Pyramid Ent Co., Ltd. (1 510(k)s)
- Seven Seas Distribtion and Manufacturing, LLC (1 510(k)s)
- Seven Sons , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Seven Harvest Intl. Import & Export?
FDA lists 7 510(k) clearances under the applicant name “Seven Harvest Intl. Import & Export” (first 1981, latest 1994), across 6 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 Seven Harvest Intl. Import & Export?
The median time from FDA receipt to decision across 510(k)s cleared under the name Seven Harvest Intl. Import & Export is 35 days.
Which FDA product codes appear under Seven Harvest Intl. Import & Export?
The most frequent FDA product codes under this applicant name are BYX (Tubing, Pressure And Accessories, 2); BTT (Humidifier, Respiratory Gas, (Direct Patient Interface), 1); BYG (Mask, Oxygen, 1).
Next steps
- See all 7 Seven Harvest Intl. Import & Export clearances with predicates and recalls
- Run predicate analysis for product code BYX, Seven Harvest Intl. Import & Export'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.