Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5180](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5180) → FPY — Sheet, Burn # FPY · Sheet, Burn _General Hospital · 21 CFR 880.5180 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY ## Overview - **Product Code:** FPY - **Device Name:** Sheet, Burn - **Regulation:** [21 CFR 880.5180](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5180) - **Device Class:** 1 - **Review Panel:** [General Hospital](/submissions/HO) ## Identification A burn sheet is a device made of a porous material that is wrapped aroung a burn victim to retain body heat, to absorb wound exudate, and to serve as a barrier against contaminants. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. ## Recent Cleared Devices (17 of 17) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K930759](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY/K930759.md) | CP & S STERILE BURN SHEET | Consolidated Products & Services, Inc. | Jan 21, 1994 | SESE | | [K926290](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY/K926290.md) | BURN SHEET | Gam Industries, Inc. | Apr 20, 1993 | SESE | | [K921471](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY/K921471.md) | BURNSHIELD TRAUMA DRESSING | Levtrade Intl. (Pty) , Ltd. | Apr 20, 1993 | SESE | | [K921470](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY/K921470.md) | BURNSHIELD FIRE BLANKET | Levtrade Intl. (Pty) , Ltd. | Apr 20, 1993 | SESE | | [K900443](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY/K900443.md) | BURNS CASUALTY SHEET LIMB WRAP | Pilgrim Medical Services | Jul 3, 1990 | SESE | | [K900442](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY/K900442.md) | BURNS CASUALTY SHEET BURN ROLL | Pilgrim Medical Services | Jul 3, 1990 | SESE | | [K900441](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY/K900441.md) | BURNS CASUALTY SHEET | Pilgrim Medical Services | Jul 3, 1990 | SESE | | [K871740](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY/K871740.md) | LYOSHEET SURGICAL SHEET FOR BURNS | Acme United Corp. | Jun 9, 1987 | SESE | | [K853145](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY/K853145.md) | KENDALL CURITY BURN PAD | The Kendal Co. | Aug 30, 1985 | SN | | [K841898](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY/K841898.md) | FIRST RESPONSE EMERG. MEDICSL - BURNS | Reed Products, Inc. | Aug 14, 1984 | SESE | | [K820994](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY/K820994.md) | ABSORB FURN SHEET | American Convertors Div., American Pharmaseal | May 13, 1982 | SESE | | [K800064](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY/K800064.md) | WATER JEL FIRE BLANKET | Trilling Resources, Ltd. | Mar 25, 1980 | SESE | | [K792433](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY/K792433.md) | TEMPORARY BURN SHEET WITH PERFORATED | American Medical Disposable, Inc. | Dec 20, 1979 | SESE | | [K792432](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY/K792432.md) | TEMPORARY BURN SHEET WITH PERFORATED | American Medical Disposable, Inc. | Dec 20, 1979 | SESE | | [K780418](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY/K780418.md) | BURN DRESSING PAD | The Owenby Co. | Apr 10, 1978 | SESE | | [K760365](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY/K760365.md) | BLANKET, BURN | Winn Hirsch & Assoc. | Aug 11, 1976 | SESE | | [K760210](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY/K760210.md) | BLANKET, WATER-JEL FIRE | American Safety | Aug 11, 1976 | SESE | ## Top Applicants - Pilgrim Medical Services — 3 clearances - American Medical Disposable, Inc. — 2 clearances - Levtrade Intl. (Pty) , Ltd. — 2 clearances - Acme United Corp. — 1 clearance - American Convertors Div., American Pharmaseal — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com