Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Essex Cryogenics of Missouri, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
238 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131990 | OXYGEN GENERATOR LIQUEFIER - (OGL) | Essex Cryogenics of Missouri, Inc. | 2014-02-21 | 238 | 0 |
| K071581 | BACKPACK MEDICAL OXYGEN SYSTEM | Essex Cryogenics of Missouri, Inc. | 2007-07-11 | 33 | 0 |
| K033000 | NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM | Essex Cryogenics of Missouri, Inc. | 2004-03-22 | 179 | 0 |
| K022684 | PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS) | Essex Cryogenics of Missouri, Inc. | 2002-09-11 | 30 | 0 |
| K880183 | PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT | Essex Cryogenics of Missouri, Inc. | 1988-04-14 | 90 | 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