Atlas FDA

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

Simmler & Son, Inc. — Predicate Candidate Screening

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

73 daysmedian FDA review time
73 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K780817GLOBIN-TERGESimmler & Son, Inc.1978-07-27700
K771906PHOSPHATESimmler & Son, Inc.1977-12-06600
K771905GLYCEROL SUBSTRATESimmler & Son, Inc.1977-12-06600
K771903LIPASESimmler & Son, Inc.1977-12-06600
K771904GLYCEROL KINASESimmler & Son, Inc.1977-12-06600
K761086REAGENTSSimmler & Son, Inc.1977-01-12580
K760476REAGENT, LACTATE DEHYDROGENASESimmler & Son, Inc.1976-11-01760
K760480REAGENT, TOTAL PROTEIN DETERMINATIONSimmler & Son, Inc.1976-10-29730
K760473REAGENT, ALBUMIN DETERMINATIONSimmler & Son, Inc.1976-10-29730
K760479REAGENT, TOTAL BILIRUBIN DETERMINATIONSimmler & Son, Inc.1976-10-29730
K760478REAGENT, BUN (UREA NITROGEN) DETERM.Simmler & Son, Inc.1976-10-29730
K760474REAGENT, ALKALINE PHOSPHATASE DETERM.Simmler & Son, Inc.1976-10-29730
K760475REAGENT, CALCIUM DETERMINATIONSimmler & Son, Inc.1976-10-29730
K760477REAGENTS-4 FOR URIC ACID DETERMINATIONSimmler & Son, Inc.1976-10-29730

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