Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Elite Technology, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
144 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K900733 | PROTEIN TEST FOR URINE AND CSF | Elite Technology, Inc. | 1990-07-10 | 144 | 0 |
| K901001 | URIC ACID TEST KIT | Elite Technology, Inc. | 1990-05-23 | 82 | 0 |
| K901090 | ELITECH GAMMA GT TEST KIT | Elite Technology, Inc. | 1990-03-29 | 22 | 0 |
| K895951 | CHOLESTEROL TEST KIT | Elite Technology, Inc. | 1990-02-16 | 128 | 0 |
| K895952 | TRIGLYCERIDES TEST KIT | Elite Technology, Inc. | 1990-01-11 | 92 | 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