Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pan-America Hyperbarics, 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) |
|---|---|---|---|---|---|
| K122560 | VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1 | Pan-America Hyperbarics, Inc. | 2013-03-26 | 216 | 0 |
| K021689 | PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PA | Pan-America Hyperbarics, Inc. | 2002-10-24 | 154 | 0 |
| K021693 | PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH | Pan-America Hyperbarics, Inc. | 2002-10-24 | 155 | 0 |
| K021690 | PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH | Pan-America Hyperbarics, Inc. | 2002-10-24 | 155 | 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