Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
T. G. & E. Medical — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
112 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K860706 | IV BAND (INTRAVENOUS CATHETER ASSESORY) | T. G. & E. Medical | 1986-03-21 | 23 | 0 |
| K860261 | CANNULA BAND | T. G. & E. Medical | 1986-02-18 | 25 | 0 |
| K823221 | ACCA-TEMP SKIN TEMP. VINYL DISC | T. G. & E. Medical | 1983-01-12 | 75 | 0 |
| K820941 | THERMA-SCAN | T. G. & E. Medical | 1982-06-16 | 71 | 0 |
| K813199 | SKIN TEMPERATURE SENSING VINYL STRIP | T. G. & E. Medical | 1982-03-05 | 112 | 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