Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tico Medical Instruments, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K911658 | DIALYSIS TRANDSDUCER PROTECTOR | Tico Medical Instruments, Inc. | 1991-08-12 | 122 | 0 |
| K884938 | VITAL SIGNS MONITOR | Tico Medical Instruments, Inc. | 1989-04-19 | 142 | 0 |
| K842985 | T- EXTENSION SET T-04-C | Tico Medical Instruments, Inc. | 1984-08-07 | 8 | 0 |
| K840443 | RETROGRADE INFUSION SET 3ML & 6ML- | Tico Medical Instruments, Inc. | 1984-04-17 | 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