Atlas FDA

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

JQF — Predicate Candidate Screening

8 FDA 510(k) clearances under this product code; the 50 most recent screened below.

63 daysmedian FDA review time
199 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K051111SENTINEL UIBC LIQUIDSentinel Ch. Srl2005-11-171990
K984122WAKO L-TYPE UIBC, WAKO UIBC CALIBRATORWako Chemicals USA, Inc.1999-01-20630
K875176WAKO(TM) UIBCWako Chemicals USA, Inc.1988-02-02470
K863066TRANSFERMETERJ. D. Assoc.1986-12-041140
K830032TOTAL IRON BINDING CAPACITY TESTSclavo, Inc.1983-01-28210
K811942J & S IRON SATURATING REAGENTThyroid Diagnostics, Inc.1981-09-08630
K810086IRON & TICBBio-Analytics Laboratories, Inc.1981-01-28150
K792409ELVI TOTAL IRON BINDING CAPACITYVolu Sol Medical Industries1979-12-06100

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