Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sequal Technologies, 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) |
|---|---|---|---|---|---|
| K083163 | OMNI 2 OXYGEN SYSTEM | Sequal Technologies, Inc. | 2009-10-20 | 358 | 0 |
| K042262 | INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10 | Sequal Technologies, Inc. | 2004-09-10 | 18 | 0 |
| K013931 | OMNI OXYGEN SYSTEM, MODEL 1000 | Sequal Technologies, Inc. | 2002-03-27 | 119 | 1 |
| K003472 | INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM | Sequal Technologies, Inc. | 2001-06-04 | 208 | 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