FDA product code FRR: Chamber, Reverse Isolation, Patient Care
FRR is the FDA product code for chamber, reverse isolation, patient care. It is a Class II device, regulated under 21 CFR 880.5450 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under FRR. The average 510(k) review took 673 days (median 673).
Classification
| Field | Value |
|---|---|
| Device name | Chamber, Reverse Isolation, Patient Care |
| Device class | Class II |
| Regulation | 21 CFR 880.5450 |
| 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 FRR clearance
Top FRR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Viva-Tek Assoc., Inc. | 1 | 1994-03-09 |
Most recent FRR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K922110 | Viva-Tek Assoc., Inc. | GO-CLEAN | 1994-03-09 | 673 |
Recalls for FRR devices
openFDA lists no recalls for product code FRR.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- G0379 — Direct admission of patient for hospital observation care
Frequently asked questions
What is FDA product code FRR?
FRR is the FDA product code for chamber, reverse isolation, patient care. It is a Class II device, regulated under 21 CFR 880.5450 and reviewed by the General Hospital panel.
What device class is FRR?
Class II, regulation 21 CFR 880.5450. Typical premarket route: 510(k).
How long does a 510(k) take for product code FRR?
Across 1 cleared submissions the average was 673 days from receipt to decision (median 673).
Which companies have the most FRR clearances?
Viva-Tek Assoc., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FRR
- Run a recall and safety report across every FRR manufacturer
- Watch product code FRR 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.
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