Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Analytic Technology — Predicate Candidate Screening

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

82 daysmedian FDA review time
150 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K921604TOUCH N' HEAT, MODIFICATIONAnalytic Technology1992-08-241500
K915243TOUCH 'N HEAT MODEL 5002, MODIFICATIONAnalytic Technology1992-01-21820
K890735COATED APEX PROBEAnalytic Technology1989-04-19650
K864500ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001Analytic Technology1987-03-191250
K832179HOT PROBE MODEL 6001Analytic Technology1983-10-04900
K823486TOUCH-N-HEAT MODEL 5001Analytic Technology1983-01-18560
K820598HOT & COLD PULP TESTER #4001Analytic Technology1982-03-19150
K801974ANALYTIC TECH. METAL POINT HEATER #3001Analytic Technology1980-11-12850
K790799PULPTESTER MODEL 2001Analytic Technology1979-05-31370

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