Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Thermedics, 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) |
|---|---|---|---|---|---|
| K894131 | DERMAPORT VASCULAR ACCESS DEVICE MODEL NO. 50-1000 | Thermedics, Inc. | 1989-09-26 | 105 | 0 |
| K863128 | PERITONEAL DIALYSIS CATHETERS | Thermedics, Inc. | 1986-09-09 | 25 | 0 |
| K854966 | ACUTE PERITONEAL DIALYSIS CATHETERS | Thermedics, Inc. | 1986-01-09 | 29 | 0 |
| K850076 | WOUND DRESSING MODEL ZB-6 | Thermedics, Inc. | 1985-04-15 | 96 | 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