Bedpan
The Bedpan is a portable receptacle used for the collection of urine and feces from patients who are unable to use a conventional toilet due to immobility or medical condition. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FOB, regulated under 21 CFR 880.6730 in the General Hospital specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- FOB
- Device Class
- FDA class 1
- Regulation Number
- 880.6730
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K791346 | DISPOSABLE BEDPAN | Aug 03, 1979 | Substantially Equivalent | General Clinical Plastics Corp. |
| K780370 | STAND UP TOILET | Apr 10, 1978 | Substantially Equivalent | Medical Specialty Products, Inc. |
| K760490 | BEDPAN, GENERAL MEDICAL MEDI-PAK | Nov 12, 1976 | Substantially Equivalent | Landmark Plastics |
| K760393 | BED PAN, STACKABLE (AUTOCLAVABLE) | Aug 23, 1976 | Substantially Equivalent | Bemis Health Care |
| K760307 | BEDPAN, SINGLE PATIENT USE, TECNOL | Aug 11, 1976 | Substantially Equivalent | Tecnol New Jersey Wound Care, Inc. |
FEI Numbers
This FDA classification entry is associated with 117 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 117 registration numbers. Click on an entry to view related FDA registrations.