Pad, Eye
The Eye Pad is a simple ophthalmic accessory placed over the closed eyelid to protect the eye following injury, surgery, or examination, providing mechanical protection and absorbing ocular discharge. It is classified as FDA Class 1, the lowest risk level, subject only to general controls without a premarket notification requirement. The product code is HMP, regulated under 21 CFR 878.4440, within the General and Plastic Surgery medical specialty. No special risk flags apply to this device.
Basic Information
- Product Code
- HMP
- Device Class
- FDA class 1
- Regulation Number
- 878.4440
- Medical Specialty
- General, Plastic Surgery
- 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 |
|---|---|---|---|---|
| K940333 | EYE PAD | Mar 07, 1994 | Substantially Equivalent | Certified Safety Mfg., Inc. |
| K921349 | STERILE,DISPOSABLE EYE DRESSING | May 29, 1992 | Substantially Equivalent | Deroyal Industries, Inc. |
| K904896 | EYE PAD | Dec 05, 1990 | Substantially Equivalent | Ulti-Med Intl., Inc. |
| K883822 | FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309 | Nov 22, 1988 | Unknown | Consolidated Industries of Greater Syracuse, Inc. |
| K874411 | DONALDSON NATURAL EYEPATCH 'PATIENT PAK' | Jan 27, 1988 | Substantially Equivalent | Keeler Instruments, Inc. |
| K864810 | LIDSPLINT | Jan 20, 1987 | Substantially Equivalent | Precision Therapeutics, Inc. |
| K861456 | SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR | Jul 25, 1986 | Substantially Equivalent for Some Indications | Pantheon Products, Inc. |
| K860979 | DONALDSON NATURAL EYEPATCH | Apr 04, 1986 | Substantially Equivalent | Keeler Instruments, Inc. |
| K851906 | SURGICAL EYE PACK | May 21, 1985 | Substantially Equivalent | Xanmed Corp. |
| K850099 | VISOPROTECT: OCCULAR SHIELD | Mar 20, 1985 | Substantially Equivalent | Rockway Enterprises, Inc. |
| K850005 | VISOPROTECT OCCULAR SHIELD | Mar 20, 1985 | Substantially Equivalent | M.S.G. Health Systems, Inc. |
| K843197 | VISITEC EYE SHIELD | Oct 05, 1984 | Substantially Equivalent | Visitec Co. |
| K803145 | CONPHAR EYE PROTECTOR | Feb 05, 1981 | Substantially Equivalent | Conphar, Inc. |
| K802799 | EYE PADS | Dec 17, 1980 | Substantially Equivalent | Secol Co. |
| K801995 | EYE PADS CAT.#581-599 | Sep 09, 1980 | Substantially Equivalent | Pollak (Intl.), Ltd. |
| K800404 | MEDSPEC OPERATIVE OPTHALMIC KIT | Apr 24, 1980 | Substantially Equivalent | Medi-Spec |
| K781539 | ISO-CARE KIT | Nov 03, 1978 | Substantially Equivalent | Nice-Pak Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 172 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 172 registration numbers. Click on an entry to view related FDA registrations.