Essex Cryogenics of Missouri, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Essex Cryogenics of Missouri, Inc.” (first 1988, latest 2014), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 238 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BYJ | Unit, Liquid-Oxygen, Portable | 3 | 3 |
| CAW | Generator, Oxygen, Portable | 2 | 2 |
Review panels
- Anesthesiology (5)
Most recent Essex Cryogenics of Missouri, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131990 | OXYGEN GENERATOR LIQUEFIER - (OGL) | CAW | 2014-02-21 | 238 |
| K071581 | BACKPACK MEDICAL OXYGEN SYSTEM | BYJ | 2007-07-11 | 33 |
| K033000 | NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM | BYJ | 2004-03-22 | 179 |
| K022684 | PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS) | CAW | 2002-09-11 | 30 |
| K880183 | PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT | BYJ | 1988-04-14 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Essex Cryogenics of Missouri, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Essex Industries, Inc. (4 510(k)s)
- Essex Industries, Inc. D/B/A Essex Cryogenics of M (1 510(k)s)
- Essex Medical Systems Plus (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Essex Cryogenics of Missouri, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Essex Cryogenics of Missouri, Inc.” (first 1988, latest 2014), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Essex Cryogenics of Missouri, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Essex Cryogenics of Missouri, Inc. is 90 days.
Which FDA product codes appear under Essex Cryogenics of Missouri, Inc.?
The most frequent FDA product codes under this applicant name are BYJ (Unit, Liquid-Oxygen, Portable, 3); CAW (Generator, Oxygen, Portable, 2).
Next steps
- See all 5 Essex Cryogenics of Missouri, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BYJ, Essex Cryogenics of Missouri, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.