Sheet, Burn
The Burn Sheet is a sterile or non-sterile covering applied to large burn areas on a patient's body to protect the wound from contamination, reduce fluid loss, and provide comfort during emergency treatment and transport. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FPY, regulated under 21 CFR 880.5180 in the General Hospital specialty.
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Basic Information
- Product Code
- FPY
- Device Class
- FDA class 1
- Regulation Number
- 880.5180
- Medical Specialty
- General Hospital
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 17 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K930759 | CP & S STERILE BURN SHEET | Jan 21, 1994 | Substantially Equivalent | Consolidated Products & Services, Inc. |
| K926290 | BURN SHEET | Apr 20, 1993 | Substantially Equivalent | Gam Industries, Inc. |
| K921471 | BURNSHIELD TRAUMA DRESSING | Apr 20, 1993 | Substantially Equivalent | Levtrade Intl. (Pty) , Ltd. |
| K921470 | BURNSHIELD FIRE BLANKET | Apr 20, 1993 | Substantially Equivalent | Levtrade Intl. (Pty) , Ltd. |
| K900443 | BURNS CASUALTY SHEET LIMB WRAP | Jul 03, 1990 | Substantially Equivalent | Pilgrim Medical Services |
| K900442 | BURNS CASUALTY SHEET BURN ROLL | Jul 03, 1990 | Substantially Equivalent | Pilgrim Medical Services |
| K900441 | BURNS CASUALTY SHEET | Jul 03, 1990 | Substantially Equivalent | Pilgrim Medical Services |
| K871740 | LYOSHEET SURGICAL SHEET FOR BURNS | Jun 09, 1987 | Substantially Equivalent | Acme United Corp. |
| K853145 | KENDALL CURITY BURN PAD | Aug 30, 1985 | Substantially Equivalent for Some Indications | The Kendal Co. |
| K841898 | FIRST RESPONSE EMERG. MEDICSL - BURNS | Aug 14, 1984 | Substantially Equivalent | Reed Products, Inc. |
| K820994 | ABSORB FURN SHEET | May 13, 1982 | Substantially Equivalent | American Convertors Div., American Pharmaseal |
| K800064 | WATER JEL FIRE BLANKET | Mar 25, 1980 | Substantially Equivalent | Trilling Resources, Ltd. |
| K792433 | TEMPORARY BURN SHEET WITH PERFORATED | Dec 20, 1979 | Substantially Equivalent | American Medical Disposable, Inc. |
| K792432 | TEMPORARY BURN SHEET WITH PERFORATED | Dec 20, 1979 | Substantially Equivalent | American Medical Disposable, Inc. |
| K780418 | BURN DRESSING PAD | Apr 10, 1978 | Substantially Equivalent | The Owenby Co. |
| K760365 | BLANKET, BURN | Aug 11, 1976 | Substantially Equivalent | Winn Hirsch & Assoc. |
| K760210 | BLANKET, WATER-JEL FIRE | Aug 11, 1976 | Substantially Equivalent | American Safety |
FEI Numbers
This FDA classification entry is associated with 58 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 58 registration numbers. Click on an entry to view related FDA registrations.