Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tri/Bor Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
165 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K904717 | MICRO-VENT NEBULIZER SYSTEM | Tri/Bor Medical, Inc. | 1991-04-01 | 165 | 0 |
| K904718 | AERO-GEN NUBULIZER SYSTEM | Tri/Bor Medical, Inc. | 1991-04-01 | 165 | 0 |
| K904719 | DISPOSABLE FACE MASK | Tri/Bor Medical, Inc. | 1991-01-02 | 76 | 0 |
| K904715 | OXYGEN/AIR TUBING | Tri/Bor Medical, Inc. | 1991-01-02 | 76 | 0 |
| K904716 | AERO-GEN NEBULIZER | Tri/Bor Medical, Inc. | 1991-01-02 | 76 | 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