| Device Type ID | 2514 |
| Device Name | Filter, Bacterial, Breathing-circuit |
| Regulation Description | Breathing Circuit Bacterial Filter. |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Infection Control Devices Branch (INCB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5260 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CAH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 2514 |
| Device | Filter, Bacterial, Breathing-circuit |
| Product Code | CAH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Breathing Circuit Bacterial Filter. |
| CFR Regulation Number | 868.5260 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EXCELERON MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FISHER & PAYKEL HEALTHCARE LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GALEMED CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GALEMED CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTERSURGICAL INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VR MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Leak / Splash | 28 |
Device Operates Differently Than Expected | 18 |
Material Discolored | 16 |
Tear, Rip Or Hole In Device Packaging | 16 |
Partial Blockage | 15 |
Material Separation | 13 |
Detachment Of Device Or Device Component | 11 |
Break | 8 |
Infusion Or Flow Problem | 8 |
Crack | 7 |
Restricted Flow Rate | 7 |
Air Leak | 7 |
Device Contamination With Chemical Or Other Material | 6 |
Failure To Infuse | 5 |
Occlusion Within Device | 5 |
Bacterial Filter | 3 |
Product Quality Problem | 3 |
Device Inoperable | 3 |
Detachment Of Device Component | 3 |
Sticking | 3 |
Complete Blockage | 3 |
Moisture Or Humidity Problem | 3 |
Improper Flow Or Infusion | 3 |
Inaccurate Delivery | 2 |
Device Dislodged Or Dislocated | 2 |
Sediment, Precipitate Or Deposit In Device Or Device Ingredient | 2 |
Appropriate Term/Code Not Available | 1 |
Disassembly | 1 |
Component Missing | 1 |
Failure To Deliver | 1 |
Obstruction Of Flow | 1 |
Increase In Pressure | 1 |
Connection Problem | 1 |
Fracture | 1 |
Gas Leak | 1 |
Split | 1 |
Blocked Connection | 1 |
Packaging Problem | 1 |
Insufficient Information | 1 |
Filter | 1 |
Disconnection | 1 |
Moisture Damage | 1 |
Device Issue | 1 |
Installation-Related Problem | 1 |
Contamination Of Device Ingredient Or Reagent | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
| Total Device Problems | 220 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | King Systems Corp. Dba Ambu, Inc. | II | Jan-05-2018 |
| 2 | Pall Corporation | II | Jul-10-2014 |
| 3 | Vital Signs Colorado Inc. | II | Jan-23-2014 |