Atlas FDA

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

Novacon Corp. — Predicate Candidate Screening

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

195 daysmedian FDA review time
395 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K992015FREEDOM INFUSION SYSTEMNovacon Corp.1999-09-10870
K955849DIB INFUSORNovacon Corp.1996-08-052220
K960318DIB INFUSOR-RANovacon Corp.1996-08-051950
K944665DIB INFUSORSNovacon Corp.1995-02-141550
K941766DIB INFUSORNovacon Corp.1994-08-051160
K930404DIB INFUSORNovacon Corp.1994-02-253950

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