| Device Type ID | 88 |
| Device Name | Regulator, Pressure, Gas Cylinder |
| Regulation Description | Pressure Regulator. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 868.2700 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CAN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 88 |
| Device | Regulator, Pressure, Gas Cylinder |
| Product Code | CAN |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Pressure Regulator. |
| CFR Regulation Number | 868.2700 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ESSEX INDUSTRIES, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 6 |
Regulator | 5 |
Flare Or Flash | 4 |
Device Operates Differently Than Expected | 4 |
Infusion Or Flow Problem | 4 |
Valve, Inlet Port | 4 |
Break | 4 |
Crack | 3 |
Cylinder | 3 |
Burst Container Or Vessel | 3 |
Inaccurate Flow Rate | 2 |
Device Inoperable | 2 |
Gauges/Meters | 2 |
Device Handling Problem | 2 |
Detachment Of Device Component | 2 |
Detachment Of Device Or Device Component | 2 |
Improper Flow Or Infusion | 1 |
Insufficient Information | 1 |
Display Or Visual Feedback Problem | 1 |
Component Falling | 1 |
Device Damaged Prior To Use | 1 |
Mechanics Altered | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Material Separation | 1 |
Increase In Pressure | 1 |
Connection Problem | 1 |
Explosion | 1 |
Use Of Device Problem | 1 |
Failure To Deliver | 1 |
No Flow | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Misconnection | 1 |
Medical Gas Supply Problem | 1 |
Sparking | 1 |
| Total Device Problems | 70 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Dynarex Corporation | II | May-29-2018 |
| 2 | Precision Medical, Inc. | II | Nov-13-2015 |
| 3 | Western / Scott Fetzer Company | I | Jul-20-2015 |
| 4 | Western / Scott Fetzer Company | II | Jun-23-2014 |