| Device Type ID | 2682 |
| Device Name | Sterilizer, Chemical |
| Regulation Description | Ethylene Oxide Gas Sterilizer. |
| Regulation Medical Specialty | General Hospital |
| 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 | 880.6860 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MLR |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 2682 |
| Device | Sterilizer, Chemical |
| Product Code | MLR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ethylene Oxide Gas Sterilizer. |
| CFR Regulation Number | 880.6860 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADVANCED STERILIZATION PRODUCTS | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
STERILUCENT, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
| Device Problems | |
|---|---|
Environmental Particulates | 490 |
Device Emits Odor | 446 |
Appropriate Term/Code Not Available | 174 |
Chemical Spillage | 36 |
Chemical Problem | 29 |
Device Handling Problem | 28 |
Fluid Leak | 7 |
Device Disinfection Or Sterilization Issue | 5 |
Improper Or Incorrect Procedure Or Method | 4 |
Device Operates Differently Than Expected | 3 |
Contamination / Decontamination Problem | 2 |
Use Of Device Problem | 2 |
Degraded | 2 |
Mechanical Problem | 2 |
Moisture Or Humidity Problem | 1 |
Positioning Problem | 1 |
Material Protrusion / Extrusion | 1 |
Leak / Splash | 1 |
Smoking | 1 |
Electrical Power Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Ventilation Problem In Device Environment | 1 |
Expiration Date Error | 1 |
| Total Device Problems | 1239 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Advanced Sterilization Products | II | Feb-14-2017 |
| 2 | Advanced Sterilization Products | II | Aug-13-2015 |
| 3 | Advanced Sterilization Products | II | Dec-22-2014 |
| 4 | Advanced Sterilization Products | II | Jan-14-2014 |
| 5 | Steris Corporation | II | Aug-31-2018 |
| 6 | Steris Corporation | II | Feb-13-2018 |