Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stackhouse, 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) |
|---|---|---|---|---|---|
| K003194 | STACKHOUSE LENS HOOD, MODEL SA-700/FS | Stackhouse, Inc. | 2000-10-26 | 14 | 0 |
| K000605 | STACKHOUSE LENS HOOD, MODEL SA-700/F | Stackhouse, Inc. | 2000-08-17 | 176 | 0 |
| K001082 | STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100 | Stackhouse, Inc. | 2000-06-15 | 72 | 14 |
| K944116 | FREEDOM ASPIRATOR, MODEL 6000 | Stackhouse, Inc. | 1994-09-07 | 15 | 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