Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
D.A. Schulman, 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) |
|---|---|---|---|---|---|
| K883681 | DAS SPORT PUMP(TM) | D.A. Schulman, Inc. | 1988-09-30 | 32 | 0 |
| K872739 | SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION | D.A. Schulman, Inc. | 1987-07-30 | 21 | 0 |
| K855004 | SWELL-RELIEF | D.A. Schulman, Inc. | 1986-02-12 | 61 | 0 |
| K831247 | SAFE-SEAT WHEELCHAIR CUSHION | D.A. Schulman, Inc. | 1983-05-16 | 28 | 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