Definition: Holding Chambers Are Devices That Are Used With Nebulizers And Metered Dose Inhalers And Are Comprised Of A Reservoir Into Which An Aerosol Medication Is Dispensed. A Holding Chamber Uses A Valved Mouthpiece Through Which The Patient Inhales The Disp
| Device Type ID | 170 |
| Device Name | Holding Chambers, Direct Patient Interface |
| Physical State | Holding Chambers Are Frequently Made Of Plastic, And Can Be Tube Shaped. |
| Technical Method | By Holding Drugs After Aerosolization, Holding Chambers Are Intended To Minimize Delivery Of Large Aerosolized Particles Which Would Otherwise Depisit In The Mouth, Throat, Or Upper Airway |
| Target Area | Holding Chambers Contact The Mouth. The Drug They Are Holding Is Intended For The Lower Airways |
| Regulation Description | Nebulizer. |
| 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) |
| CFR Regulation Number | 868.5630 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NVP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 170 |
| Device | Holding Chambers, Direct Patient Interface |
| Product Code | NVP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nebulizer. |
| CFR Regulation Number | 868.5630 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FSC LABORATORIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THAYER MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Fragmentation | 3 |
Inadequacy Of Device Shape And/or Size | 1 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | FSC Laboratories, Inc | II | Jun-15-2016 |