Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Essex Industries, 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) |
|---|---|---|---|---|---|
| K162811 | MR Conditional CGA 870 | Essex Industries, Inc. | 2017-03-02 | 147 | 0 |
| K161472 | Walk-O2-Bout | Essex Industries, Inc. | 2016-11-18 | 175 | 0 |
| K113767 | MOUNTED MEDICAL OXYGEN SYSTEM | Essex Industries, Inc. | 2012-06-29 | 191 | 0 |
| K101272 | MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 | Essex Industries, Inc. | 2010-08-20 | 106 | 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