Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Environmental Tectonics Corp. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092991 | O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) | Environmental Tectonics Corp. | 2010-08-13 | 319 | 0 |
| K020974 | BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER | Environmental Tectonics Corp. | 2002-06-26 | 92 | 0 |
| K993010 | BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER | Environmental Tectonics Corp. | 2000-05-30 | 266 | 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