FDA product code MRB: Indicator, Biological, Liquid Chemical Sterilization Process
MRB is the FDA product code for indicator, biological, liquid chemical sterilization process. It is a Class II device, regulated under 21 CFR 880.2800 and reviewed by the General Hospital panel. FDA has cleared 4 510(k) submissions under MRB, from 2 different applicants. The average 510(k) review took 128 days (median 76).
Classification
| Field | Value |
|---|---|
| Device name | Indicator, Biological, Liquid Chemical Sterilization Process |
| Device class | Class II |
| Regulation | 21 CFR 880.2800 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every MRB clearance
Top MRB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spsmedical Supply Corp. | 2 | 2008-07-30 |
| Raven Biological Laboratories, Inc. | 2 | 2006-02-15 |
Most recent MRB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K081879 | Spsmedical Supply Corp. | SPSMEDICAL SPORVIEW PA CULTURE SET | 2008-07-30 | 28 |
| K053212 | Raven Biological Laboratories, Inc. | RAVEN PROPACT | 2006-02-15 | 91 |
| K043135 | Spsmedical Supply Corp. | SPSMEDICAL SPORVIEW PA CULTURE SET | 2005-01-13 | 62 |
| K031114 | Raven Biological Laboratories, Inc. | PRO-PACT PERACETIC ACID CULTURE TEST KIT, MODEL C-3PA | 2004-03-03 | 330 |
Recalls for MRB devices
openFDA lists no recalls for product code MRB.
Frequently asked questions
What is FDA product code MRB?
MRB is the FDA product code for indicator, biological, liquid chemical sterilization process. It is a Class II device, regulated under 21 CFR 880.2800 and reviewed by the General Hospital panel.
What device class is MRB?
Class II, regulation 21 CFR 880.2800. Typical premarket route: 510(k).
How long does a 510(k) take for product code MRB?
Across 4 cleared submissions the average was 128 days from receipt to decision (median 76).
Which companies have the most MRB clearances?
Spsmedical Supply Corp. (2); Raven Biological Laboratories, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code MRB
- Run a recall and safety report across every MRB manufacturer
- Watch product code MRB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times