Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stephenson Industries, 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) |
|---|---|---|---|---|---|
| K963777 | HYPER PULSE INTERMITTENT TOPICAL OXYGEN CHAMBER C-100, CB-10 | Stephenson Industries, Inc. | 1997-07-28 | 311 | 0 |
| K861593 | TOPICAL HYPERBARIC OXYGEN CHAMBER | Stephenson Industries, Inc. | 1986-05-12 | 13 | 0 |
| K861101 | THE NEW FLEXIBLE COLLAPSIBLE CHAMBER | Stephenson Industries, Inc. | 1986-05-06 | 43 | 0 |
| K853971 | REGULATOR-INHALATOR SYSTEM | Stephenson Industries, Inc. | 1985-12-09 | 74 | 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