Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Seven Harvest Intl. Import & Export — Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

35 daysmedian FDA review time
129 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K940793DOUBLE TRACH SWIVEL CONNECTORSeven Harvest Intl. Import & Export1994-07-011290
K823506NASAL CANNULASeven Harvest Intl. Import & Export1982-12-09150
K823141OXYGEN MASKSSeven Harvest Intl. Import & Export1982-11-29350
K823143BUBBLE HUMIDIFIERSSeven Harvest Intl. Import & Export1982-11-29350
K823142OXYGEN TUBINGSSeven Harvest Intl. Import & Export1982-11-29350
K820709AIRWAYSSeven Harvest Intl. Import & Export1982-06-25990
K813074CONNECTORS & ADAPTERSSeven Harvest Intl. Import & Export1981-12-31590

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda