FDA product code ECX: Cylinder, Compressed Gas, And Valve
ECX is the FDA product code for cylinder, compressed gas, and valve. It is a Class I device, regulated under 21 CFR 868.2700 and reviewed by the Anesthesiology panel. FDA has cleared 13 510(k) submissions under ECX, from 12 different applicants. The average 510(k) review took 207 days (median 209). FDA has posted 18 recalls for ECX devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cylinder, Compressed Gas, And Valve |
| Device class | Class I |
| Regulation | 21 CFR 868.2700 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for ECX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 352 |
Compare with all 510(k) review times · Search every ECX clearance
Top ECX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Air Liquide Healthcare America | 2 | 2014-03-14 |
| Air Liquide Healthcare America Corporation | 1 | 2017-04-13 |
| Essex Industries, Inc. | 1 | 2016-11-18 |
| Praxair Distribution, Incorporated. | 1 | 2016-06-03 |
| Air Liquide Healthcare | 1 | 2015-05-21 |
7 more applicants have ECX clearances. See the full list in Caduvo.
Most recent ECX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K161179 | Air Liquide Healthcare America Corporation | Intelli-Ox | 2017-04-13 | 352 |
| K161472 | Essex Industries, Inc. | Walk-O2-Bout | 2016-11-18 | 175 |
| K153518 | Praxair Distribution, Incorporated. | Medipure Oxygen-LC System | 2016-06-03 | 178 |
| K143060 | Air Liquide Healthcare | Intelli-Ox | 2015-05-21 | 209 |
| K142149 | Western/Scott Fetzer Co. | OXYTOTE INFINITY SERIES VIPR SYSTEMS | 2015-04-17 | 255 |
Recalls for ECX devices
18 product recalls in 5 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2026-07-28.
| Year | Recalls |
|---|---|
| 2019 | 5 |
| 2021 | 1 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code ECX?
ECX is the FDA product code for cylinder, compressed gas, and valve. It is a Class I device, regulated under 21 CFR 868.2700 and reviewed by the Anesthesiology panel.
What device class is ECX?
Class I, regulation 21 CFR 868.2700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ECX?
Across 13 cleared submissions the average was 207 days from receipt to decision (median 209).
Which companies have the most ECX clearances?
Air Liquide Healthcare America (2); Air Liquide Healthcare America Corporation (1); Essex Industries, Inc. (1); Praxair Distribution, Incorporated. (1); Air Liquide Healthcare (1).
Have ECX devices been recalled?
Yes: 18 product recalls across 5 recall events; the most recent began 2026-07-28.
Next steps
- Run an FDA pathway report with predicate devices for product code ECX
- Run a recall and safety report across every ECX manufacturer
- Watch product code ECX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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