Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4440](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4440) → HMP — Pad, Eye # HMP · Pad, Eye _General, Plastic Surgery · 21 CFR 878.4440 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP ## Overview - **Product Code:** HMP - **Device Name:** Pad, Eye - **Regulation:** [21 CFR 878.4440](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4440) - **Device Class:** 1 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) ## Identification An eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. ## 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 § 878.9. ## Recent Cleared Devices (17 of 17) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K940333](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP/K940333.md) | EYE PAD | Certified Safety Mfg., Inc. | Mar 7, 1994 | SESE | | [K921349](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP/K921349.md) | STERILE,DISPOSABLE EYE DRESSING | Deroyal Industries, Inc. | May 29, 1992 | SESE | | [K904896](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP/K904896.md) | EYE PAD | Ulti-Med Intl., Inc. | Dec 5, 1990 | SESE | | [K883822](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP/K883822.md) | FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309 | Consolidated Industries of Greater Syracuse, Inc. | Nov 22, 1988 | SESD | | [K874411](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP/K874411.md) | DONALDSON NATURAL EYEPATCH 'PATIENT PAK' | Keeler Instruments, Inc. | Jan 27, 1988 | SESE | | [K864810](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP/K864810.md) | LIDSPLINT | Precision Therapeutics, Inc. | Jan 20, 1987 | SESE | | [K861456](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP/K861456.md) | SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR | Pantheon Products, Inc. | Jul 25, 1986 | SN | | [K860979](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP/K860979.md) | DONALDSON NATURAL EYEPATCH | Keeler Instruments, Inc. | Apr 4, 1986 | SESE | | [K851906](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP/K851906.md) | SURGICAL EYE PACK | Xanmed Corp. | May 21, 1985 | SESE | | [K850099](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP/K850099.md) | VISOPROTECT: OCCULAR SHIELD | Rockway Enterprises, Inc. | Mar 20, 1985 | SESE | | [K850005](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP/K850005.md) | VISOPROTECT OCCULAR SHIELD | M.S.G. Health Systems, Inc. | Mar 20, 1985 | SESE | | [K843197](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP/K843197.md) | VISITEC EYE SHIELD | Visitec Co. | Oct 5, 1984 | SESE | | [K803145](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP/K803145.md) | CONPHAR EYE PROTECTOR | Conphar, Inc. | Feb 5, 1981 | SESE | | [K802799](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP/K802799.md) | EYE PADS | Secol Co. | Dec 17, 1980 | SESE | | [K801995](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP/K801995.md) | EYE PADS CAT.#581-599 | Pollak (Intl.), Ltd. | Sep 9, 1980 | SESE | | [K800404](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP/K800404.md) | MEDSPEC OPERATIVE OPTHALMIC KIT | Medi-Spec | Apr 24, 1980 | SESE | | [K781539](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP/K781539.md) | ISO-CARE KIT | Nice-Pak Products, Inc. | Nov 3, 1978 | SESE | ## Top Applicants - Keeler Instruments, Inc. — 2 clearances - Xanmed Corp. — 1 clearance - Visitec Co. — 1 clearance - Ulti-Med Intl., Inc. — 1 clearance - Secol Co. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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