Atlas FDA

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

The Deca Co. — Predicate Candidate Screening

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

121 daysmedian FDA review time
193 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K870041FLEXIBLE FASCICULATED BONE PLATEThe Deca Co.1987-07-171930
K870040INTRAMEDULLARY NAILThe Deca Co.1987-03-26800
K863239FASCICULATED BOAT RODThe Deca Co.1986-12-241240
K863271FASCICULATED S RODThe Deca Co.1986-12-241210
K863215FASCICULATED I RODThe Deca Co.1986-12-241260
K861183INTRAMEDULLARY RODThe Deca Co.1986-08-111330
K854227FASCILULATED NAILThe Deca Co.1986-02-041090
K830087INTRAMEDULLARY RODThe Deca Co.1983-03-01490
K813340HIP PINThe Deca Co.1982-01-29650

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