FDA product code FOB: Bedpan
FOB is the FDA product code for bedpan. It is a Class I device, regulated under 21 CFR 880.6730 and reviewed by the General Hospital panel. FDA has cleared 5 510(k) submissions under FOB, from 5 different applicants. The average 510(k) review took 34 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Bedpan |
| Device class | Class I |
| Regulation | 21 CFR 880.6730 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every FOB clearance
Top FOB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| General Clinical Plastics Corp. | 1 | 1979-08-03 |
| Medical Specialty Products, Inc. | 1 | 1978-04-10 |
| Landmark Plastics | 1 | 1976-11-12 |
| Bemis Health Care | 1 | 1976-08-23 |
| Tecnol New Jersey Wound Care, Inc. | 1 | 1976-08-11 |
Most recent FOB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K791346 | General Clinical Plastics Corp. | DISPOSABLE BEDPAN | 1979-08-03 | 22 |
| K780370 | Medical Specialty Products, Inc. | STAND UP TOILET | 1978-04-10 | 34 |
| K760490 | Landmark Plastics | BEDPAN, GENERAL MEDICAL MEDI-PAK | 1976-11-12 | 81 |
| K760393 | Bemis Health Care | BED PAN, STACKABLE (AUTOCLAVABLE) | 1976-08-23 | 17 |
| K760307 | Tecnol New Jersey Wound Care, Inc. | BEDPAN, SINGLE PATIENT USE, TECNOL | 1976-08-11 | 16 |
Recalls for FOB devices
openFDA lists no recalls for product code FOB.
Frequently asked questions
What is FDA product code FOB?
FOB is the FDA product code for bedpan. It is a Class I device, regulated under 21 CFR 880.6730 and reviewed by the General Hospital panel.
What device class is FOB?
Class I, regulation 21 CFR 880.6730. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FOB?
Across 5 cleared submissions the average was 34 days from receipt to decision (median 22).
Which companies have the most FOB clearances?
General Clinical Plastics Corp. (1); Medical Specialty Products, Inc. (1); Landmark Plastics (1); Bemis Health Care (1); Tecnol New Jersey Wound Care, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FOB
- Run a recall and safety report across every FOB manufacturer
- Watch product code FOB 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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