Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
S & W Enterprises, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
56 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K864817 | S&W MODEL HIGH-LOW MAT TABLE, VARIOUS MODELS | S & W Enterprises, Inc. | 1987-01-05 | 27 | 0 |
| K841145 | TILT TABLE 53 | S & W Enterprises, Inc. | 1984-04-13 | 28 | 0 |
| K832768 | S & W SW52E W/POWER BACK LIFT | S & W Enterprises, Inc. | 1983-09-20 | 35 | 0 |
| K830873 | S & W MODEL ASO | S & W Enterprises, Inc. | 1983-05-13 | 56 | 0 |
| K830875 | S & W MODEL 29 | S & W Enterprises, Inc. | 1983-04-08 | 21 | 0 |
| K830874 | S & W MODEL SW 37 | S & W Enterprises, Inc. | 1983-04-08 | 21 | 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