Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tempo Technology, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963220 | TEMPRA COLD PACK, REORDER NO. TC150 | Tempo Technology, Inc. | 1996-10-10 | 55 | 0 |
| K934700 | MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY | Tempo Technology, Inc. | 1994-03-16 | 167 | 0 |
| K896963 | TRIMODE SP DENTAL INTRA ORAL X-RAY | Tempo Technology, Inc. | 1990-01-22 | 38 | 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