Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Comfortex, 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) |
|---|---|---|---|---|---|
| K855179 | TRANSFER-TRAX (TM) SPLINT TRACTION | Comfortex, Inc. | 1986-01-21 | 26 | 0 |
| K860037 | SUSPENDER ORTHOPEDIC SUSPENSION DEVICE | Comfortex, Inc. | 1986-01-21 | 15 | 0 |
| K855181 | COMFORTEX WHEELCHAIR CUSHION | Comfortex, Inc. | 1986-01-13 | 18 | 0 |
| K854270 | MURPHY ADJUSTABLE SPLINT | Comfortex, Inc. | 1985-12-09 | 47 | 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