Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Contour Fabricators, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
179 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090773 | CFI ULTRASOUND PROBE DRAPE | Contour Fabricators, Inc. | 2009-09-18 | 179 | 0 |
| K970900 | INSTRUMENT HOLDER | Contour Fabricators, Inc. | 1997-05-22 | 72 | 0 |
| K971040 | CABLE HOLDER, SUCTION TUBE HOLDER | Contour Fabricators, Inc. | 1997-04-16 | 26 | 0 |
| K970185 | STERILE DISPOSABLE EQUIPMENT MAGNET COVER | Contour Fabricators, Inc. | 1997-04-10 | 83 | 5 |
| K964141 | GE STERILE DISPOSABLE EQUIPMENT COIL COVER | Contour Fabricators, Inc. | 1997-01-30 | 107 | 0 |
| K963453 | CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) | Contour Fabricators, Inc. | 1996-11-15 | 73 | 0 |
| K820692 | BANDBAG, WRAP, STERILE | Contour Fabricators, Inc. | 1982-05-03 | 52 | 5 |
| K782155 | GENERAL EQUIPMENT COVER | Contour Fabricators, Inc. | 1979-01-17 | 26 | 5 |
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