Atlas FDA

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

Agamatrix — Predicate Candidate Screening

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

60 daysmedian FDA review time
132 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K241304WaveSense Jazz Blood Glucose Monitoring SystemAgamatrix2024-06-06280
K101597WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4Agamatrix2010-10-181320
K073573WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEMAgamatrix2008-01-30410
K072413MODIFICATION TO: JAZZ BLOOD GLUCOSE MONITORING SYSTEMAgamatrix2007-09-27300
K071393JAZZ BLOOD GLUCOSE MONITORING SYSTEMAgamatrix2007-07-20600
K063409LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067Agamatrix2007-01-12600
K062434ZERO-CLICK DATA MANAGEMENT SYSTEM, MODEL 8000-01528Agamatrix2006-11-13840

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