| Device Type ID | 2676 |
| Device Name | Sterilant, Medical Devices |
| Regulation Description | Liquid Chemical Sterilants/high Level Disinfectants. |
| 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 | 880.6885 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MED |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2676 |
| Device | Sterilant, Medical Devices |
| Product Code | MED |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Liquid Chemical Sterilants/high Level Disinfectants. |
| CFR Regulation Number | 880.6885 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CIDEN TECHNOLOGIES LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
| Device Problems | |
|---|---|
Device Disinfection Or Sterilization Issue | 44 |
Chemical Problem | 28 |
Improper Or Incorrect Procedure Or Method | 21 |
Labelling, Instructions For Use Or Training Problem | 20 |
Device Rinsing Issue | 17 |
Device Expiration Issue | 9 |
Inadequate Or Insufficient Training | 6 |
Device Reprocessing Problem | 6 |
Ventilation Problem In Device Environment | 5 |
Shelf Life Exceeded | 4 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Use Of Device Problem | 3 |
Appropriate Term/Code Not Available | 3 |
Improper Chemical Reaction | 2 |
Failure To Disinfect | 2 |
Off-Label Use | 2 |
Environmental Compatibility Problem | 2 |
Device Handling Problem | 2 |
Leak / Splash | 2 |
Chemical Spillage | 1 |
Device Contamination With Biological Material | 1 |
Environmental Particulates | 1 |
Human Factors Issue | 1 |
Fumes Or Vapors | 1 |
Mechanical Problem | 1 |
Residue After Decontamination | 1 |
Patient-Device Incompatibility | 1 |
Device Operational Issue | 1 |
Ambient Temperature Problem | 1 |
Test Strip | 1 |
Problem With Removal Of Enzymatic Cleaner | 1 |
| Total Device Problems | 193 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Advanced Sterilization Products | II | Sep-16-2015 |
| 2 | Advanced Sterilization Products | II | Aug-25-2015 |
| 3 | Best Sanitizers Inc | II | Sep-02-2016 |
| 4 | Steris Corporation | II | Mar-16-2016 |