FDA product code FOC: Bag, Urine Collection, Newborn
FOC is the FDA product code for bag, urine collection, newborn. It is a Class II device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under FOC, from 4 different applicants. The average 510(k) review took 46 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Bag, Urine Collection, Newborn |
| Device class | Class II |
| Regulation | 21 CFR 876.5250 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FOC clearance
Top FOC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hollister, Inc. | 1 | 1995-02-07 |
| Rimeco Products, Inc. | 1 | 1994-11-01 |
| C.R. Bard, Inc. | 1 | 1991-05-28 |
| Cavitron Corp. | 1 | 1977-08-04 |
Most recent FOC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950176 | Hollister, Inc. | PREMIE U-BAG URINE SPECIMEN COLLECTOR | 1995-02-07 | 21 |
| K943752 | Rimeco Products, Inc. | RIMECO MIDSTREAM URINE COLLECTOR | 1994-11-01 | 91 |
| K911329 | C.R. Bard, Inc. | BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE | 1991-05-28 | 63 |
| K771368 | Cavitron Corp. | PORTABLE INFANT VENTILATOR | 1977-08-04 | 10 |
Recalls for FOC devices
openFDA lists no recalls for product code FOC.
Frequently asked questions
What is FDA product code FOC?
FOC is the FDA product code for bag, urine collection, newborn. It is a Class II device, regulated under 21 CFR 876.5250 and reviewed by the Gastroenterology and Urology panel.
What device class is FOC?
Class II, regulation 21 CFR 876.5250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FOC?
Across 4 cleared submissions the average was 46 days from receipt to decision (median 42).
Which companies have the most FOC clearances?
Hollister, Inc. (1); Rimeco Products, Inc. (1); C.R. Bard, Inc. (1); Cavitron Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FOC
- Run a recall and safety report across every FOC manufacturer
- Watch product code FOC 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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