Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cal West Trading Co. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
94 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950392 | 4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050 | Cal West Trading Co. | 1995-02-21 | 20 | 0 |
| K933756 | MAGNASHIELD CPR MOUTH BARRIER | Cal West Trading Co. | 1994-01-05 | 155 | 0 |
| K920269 | EZ GAUZE SPONGE | Cal West Trading Co. | 1992-04-22 | 92 | 0 |
| K914842 | GAUZE BANDAGE ROLL | Cal West Trading Co. | 1991-12-04 | 37 | 0 |
| K912952 | BANDAGE COMPRESS | Cal West Trading Co. | 1991-10-04 | 94 | 0 |
| K912950 | COMPRESS DRESSING | Cal West Trading Co. | 1991-10-04 | 94 | 0 |
| K912953 | GAUZE COMPRESS | Cal West Trading Co. | 1991-09-30 | 90 | 0 |
| K912954 | STRETCH GAUZE BANDAGE | Cal West Trading Co. | 1991-09-10 | 70 | 0 |
| K912951 | 12-PLY GAUZE PAD | Cal West Trading Co. | 1991-09-10 | 70 | 0 |
| K912955 | EYE PAD | Cal West Trading Co. | 1991-09-10 | 70 | 0 |
| K912949 | TRIANGULAR BANDAGE,40 | Cal West Trading Co. | 1991-09-06 | 61 | 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