Atlas FDA

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

PZI — Predicate Candidate Screening

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

132 daysmedian FDA review time
816 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K252323cobas pulse blood glucose monitoring systemRoche Diagnostics2026-06-123220
K221349XPER Technology PREMIUM Pro Blood Glucose Monitoring SystemTaidoc Technology Corporation2024-11-199250
K220272cobas pulse blood glucose monitoring systemRoche Diagnostics2024-04-268160
K232075StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation2024-02-232261
K200788Assure Titanium Blood Glucose Monitoring SystemArkray, Inc.2022-05-237880
K182552StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation2018-12-13870
K182549StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation2018-12-13870
K181043StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation2018-07-12840
K163490StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation2017-01-06250
K161856StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation2016-11-151320
K152986StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation2016-01-271100
K150461StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation2015-05-20860
K150281StatStrip Glucose Hospital MeterNova Biomedical Corporation2015-05-06900
K132121STATSTRIP GLUCOSE HOSPITAL METER SYSTEMNova Biomedical Corporation2014-09-244410

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