Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
S. and H. Engineering, 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) |
|---|---|---|---|---|---|
| K962487 | BREAST TREATMENT AID M200 | S. and H. Engineering, Inc. | 1996-09-09 | 75 | 0 |
| K961467 | HEAD RETAINING DEVICE | S. and H. Engineering, Inc. | 1996-08-09 | 116 | 0 |
| K961170 | BREAST TREATMENT AID | S. and H. Engineering, Inc. | 1996-06-19 | 86 | 0 |
| K922564 | 6 FRENCH CATHETER | S. and H. Engineering, Inc. | 1992-12-17 | 199 | 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