Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Perry Baromedical Services — 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) |
|---|---|---|---|---|---|
| K983648 | SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM | Perry Baromedical Services | 1999-02-24 | 131 | 0 |
| K930748 | SIGMA MP MULTIPLACE HYPERBARIC CHAMBER | Perry Baromedical Services | 1993-08-20 | 189 | 0 |
| K895513 | PERRY SV-1 HYPERBARIC VENTILATOR | Perry Baromedical Services | 1990-12-19 | 463 | 0 |
| K862198 | SIGMA II - DUAL PLACE HYPERBARIC CHAMBER | Perry Baromedical Services | 1986-11-12 | 156 | 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