| Device Type ID | 2595 |
| Device Name | Indicator, Biological Sterilization Process |
| Regulation Description | Sterilization Process Indicator. |
| 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 | 880.2800 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FRC |
| 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 | 2595 |
| Device | Indicator, Biological Sterilization Process |
| Product Code | FRC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Sterilization Process Indicator. |
| CFR Regulation Number | 880.2800 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
3M COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
ADVANCED STERILIZATION PRODUCTS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ANDERSEN STERILIZERS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CROSSTEX INTERNATIONAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DANA PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GETINGE INFECTION CONTROL AB | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GKE-GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MESA LABORATORIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NORTH AMERICAN SCIENCE ASSOC., INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STERILUCENT, INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 17 | |
TERRAGENE SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TSO3 INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 511 |
Chemical Problem | 287 |
Device Operates Differently Than Expected | 151 |
Indicator | 14 |
Environmental Particulates | 7 |
Shelf Life Exceeded | 5 |
Insufficient Information | 2 |
Break | 2 |
Material Fragmentation | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
False Positive Result | 1 |
Sterility | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Material Separation | 1 |
Chemical Spillage | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Improper Chemical Reaction | 1 |
| Total Device Problems | 990 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | 3M Company - Health Care Business | II | Jul-07-2014 |
| 2 | Mesa Laboratories Bozeman Manufacturing Facility | II | Mar-29-2018 |
| 3 | Mesa Laboratories Inc | II | Jan-26-2017 |