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

Simmler, Inc. · Predicate Candidate Screening

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

23 daysmedian FDA review time
64 days90th percentile
23clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K895745SICKLE CELL SOLUBILITY TEST KITSimmler, Inc.1989-11-29640
K874903MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)Simmler, Inc.1988-02-11720
K874595MULTICHEM (R) MAGNESIUM REAGENTSimmler, Inc.1988-01-21730
K874820MULTICHEM HDL PRECIPITATING REAGENT #S0914Simmler, Inc.1988-01-07440
K874812MULTICHEM CHLORIDE REAGENT S0933Simmler, Inc.1987-12-18240
K874311MULTICHEM (R) TOTAL BILIRUBINSimmler, Inc.1987-11-25360
K874049MULTICHEM ALBUMIN REAGENT S0902Simmler, Inc.1987-10-29240
K874038MULTICHEM INORGANIC PHOSPHOROUS S0923Simmler, Inc.1987-10-28230
K873725MULTICHEM CREATININE REAGENT S0917Simmler, Inc.1987-10-20350
K873761MULTICHEM ALKALINE PHOSPHATASE (S0903)Simmler, Inc.1987-10-07210
K873697MULTICHEM CALCIUM S0910Simmler, Inc.1987-10-02180
K872010MULTICHEM LDH-L REAGENTSimmler, Inc.1987-06-11160
K871975MULTICHEM TOTAL PROTEIN REAGENT #S0928Simmler, Inc.1987-06-05140
K871976MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919Simmler, Inc.1987-06-05140
K853244TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZESimmler, Inc.1985-08-12110
K853049ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZESimmler, Inc.1985-08-02140
K853050CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZSimmler, Inc.1985-08-02140
K843938LINEAR ENZYMATIC URIC ACID SYSTEMSimmler, Inc.1984-10-30210
K831700MULTICHEM ENZYMATIC CHOLESTEROL SYSSimmler, Inc.1983-07-19560
K831398LINEAR ENZMATIC URIC ACID SYSTEMSimmler, Inc.1983-06-08400
K801222REAGENTS FOR ASTRA 8 AUTOMATED ANALYZERSimmler, Inc.1980-06-26340
K800200LINEAR ENZYMATIC GLUCOSE SYSTEMSimmler, Inc.1980-02-21220
K800199LINEAR ENZYMATIC CHOLESTEROL SYSTEMSimmler, Inc.1980-02-21220

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