Atlas FDA

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

Sewon Industry — Predicate Candidate Screening

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

23 daysmedian FDA review time
42 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K870996SEWON DENTAL FLOSSERSewon Industry1987-03-1980
K860769DENTAL FLOSS HOLDERSewon Industry1986-03-26230
K842846SEWON DENTAL FLOSS FOLDERSewon Industry1984-08-17280
K831254DENTAL FLOSS HOLDERSewon Industry1983-05-09210
K813248DENTAL FLOSS HOLDERSewon Industry1981-12-31420
K811926SE WON(ALUMINUM) DENTAL FLOSS HOLDERSewon Industry1981-07-28220
K811555DENTAL FLOSS HOLDERSewon Industry1981-07-01290

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