Atlas FDA

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

CKE — Predicate Candidate Screening

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

31 daysmedian FDA review time
182 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K914167CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASEEastman Kodak Company1992-03-171820
K915705ACID PHOSPHATASE REAGENT SETTech Intl. Co.1992-02-27900
K873726ACID PHOSPHATASE TESTKing Diagnostics, Inc.1988-01-271340
K864230DIMENSION (TM) CLINICAL CHEMISTRY SYSTEME.I. Dupont DE Nemours & Co., Inc.1986-11-28310
K860476ACID PHOSPHATASE REAGENT SETSterling Diagnostics, Inc.1986-03-05260
K843380ACID PHOSPHATASE ASSAY KITDiagnostic Chemicals, Ltd. (Usa)1984-09-20230
K821526ACID PHOSPHATASE REAGENT SETAnco Medical Reagents & Assoc.1982-06-10200
K800693STANBIO PROSTATIC ACID PHOSPHATASE TESTStanbio Laboratory1980-04-16200
K790524DATA-ZYME ACIA PHOSPHATASE PROCEDUREData Medical Associates, Inc.1979-05-23690

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