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-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921604 | TOUCH N' HEAT, MODIFICATION | Analytic Technology | 1992-08-24 | 150 | 0 |
| K915243 | TOUCH 'N HEAT MODEL 5002, MODIFICATION | Analytic Technology | 1992-01-21 | 82 | 0 |
| K890735 | COATED APEX PROBE | Analytic Technology | 1989-04-19 | 65 | 0 |
| K864500 | ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001 | Analytic Technology | 1987-03-19 | 125 | 0 |
| K832179 | HOT PROBE MODEL 6001 | Analytic Technology | 1983-10-04 | 90 | 0 |
| K823486 | TOUCH-N-HEAT MODEL 5001 | Analytic Technology | 1983-01-18 | 56 | 0 |
| K820598 | HOT & COLD PULP TESTER #4001 | Analytic Technology | 1982-03-19 | 15 | 0 |
| K801974 | ANALYTIC TECH. METAL POINT HEATER #3001 | Analytic Technology | 1980-11-12 | 85 | 0 |
| K790799 | PULPTESTER MODEL 2001 | Analytic Technology | 1979-05-31 | 37 | 0 |
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