Atlas FDA

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

CIO — Predicate Candidate Screening

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

31 daysmedian FDA review time
77 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K880177ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHATTech-Co, Inc.1988-04-05810
K860351ALKALINE PHOSPHATASE REAGENT SETSterling Diagnostics, Inc.1986-02-11120
K855192ALKALINE PHOSPHATASE REAGENT SETTechnostics Intl.1986-01-14190
K844498SANDARE ALKALINE PHOSPHATASE PROCEDURESandare Chemical Co., Inc.1984-12-10200
K844237ALKALINE PHOSPHATASE REAGENT SETLivonia Diagnostics, Inc.1984-11-20190
K841064ALKALINE PHOSPHOTASE REAGENT SETMedical Specialties, Inc.1984-05-01500
K823578COBAS STANDARDS FOR CALCIUM-IN-ORGANICHoffmann-La Roche, Inc.1983-01-07320
K821200ALKALINE PHOSPHOTASE REAGENT SETOmega Medical Electronics1982-07-13770
K781324ALP TESTAnalytical & Research Chemicals, Inc.1978-08-31310
K772257ALKALINE PHOSPHATASE TEST SETStanbio Laboratory1977-12-22170
K770453PHOSPHATASE PROCEDURE, TEKPOINT ALKALINEIcn Pharmaceuticals, Inc.1977-05-03560

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