Product code HMP
- Device name
- Pad, Eye
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4440
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K940333 | EYE PAD | Certified Safety Mfg., Inc. | 1994-03-07 |
| K921349 | STERILE,DISPOSABLE EYE DRESSING | Deroyal Industries, Inc. | 1992-05-29 |
| K904896 | EYE PAD | Ulti-Med Intl., Inc. | 1990-12-05 |
| K883822 | FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309 | Consolidated Industries of Greater Syracuse, Inc. | 1988-11-22 |
| K874411 | DONALDSON NATURAL EYEPATCH 'PATIENT PAK' | Keeler Instruments, Inc. | 1988-01-27 |
| K864810 | LIDSPLINT | Precision Therapeutics, Inc. | 1987-01-20 |
| K861456 | SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR | Pantheon Products, Inc. | 1986-07-25 |
| K860979 | DONALDSON NATURAL EYEPATCH | Keeler Instruments, Inc. | 1986-04-04 |
| K851906 | SURGICAL EYE PACK | Xanmed Corp. | 1985-05-21 |
| K850099 | VISOPROTECT: OCCULAR SHIELD | Rockway Enterprises, Inc. | 1985-03-20 |
| K850005 | VISOPROTECT OCCULAR SHIELD | M.S.G. Health Systems, Inc. | 1985-03-20 |
| K843197 | VISITEC EYE SHIELD | Visitec Co. | 1984-10-05 |
| K803145 | CONPHAR EYE PROTECTOR | Conphar, Inc. | 1981-02-05 |
| K802799 | EYE PADS | Secol Co. | 1980-12-17 |
| K801995 | EYE PADS CAT.#581-599 | Pollak (Intl.), Ltd. | 1980-09-09 |
| K800404 | MEDSPEC OPERATIVE OPTHALMIC KIT | Medi-Spec | 1980-04-24 |
| K781539 | ISO-CARE KIT | Nice-Pak Products, Inc. | 1978-11-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10653160388708 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-07-14 |
| 08681756010356 | Pergo | PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI | 2025-06-30 |
| 08681756010349 | Pergo | PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI | 2025-06-30 |
| 10665973018079 | American White Cross | Dukal LLC | 2022-12-06 |
| 10665973014903 | Dukal | Dukal LLC | 2022-12-06 |
| 10665973018093 | American White Cross | Dukal LLC | 2022-12-02 |
| 10850015055314 | Uline 50 Person First Aid Kit - SUB | ULINE, INC. | 2022-01-14 |
| 10850015055307 | Uline 25 Person First Aid Kit - SUB | ULINE, INC. | 2022-01-14 |
| 10653160266952 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-02 |
| 10653160318026 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-02 |
| 10653160316312 | Centurion | CENTURION MEDICAL PRODUCTS CORPORATION | 2022-01-01 |
| 00616784336015 | Oval Eye Pads, Sterile | Dynarex Corporation | 2021-06-21 |
| 00616784335919 | Oval Eye Pads, Sterile | Dynarex Corporation | 2021-06-21 |
| 10080196738557 | Medline | MEDLINE INDUSTRIES, INC. | 2021-03-22 |
| 14897106953650 | andorate® Eye Cornea Protectors | GA Health Company Limited | 2021-03-12 |
| 10193489199666 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2021-02-19 |
| 10888277702318 | MEDLINE INDUSTRIES | MEDLINE INDUSTRIES, INC. | 2021-01-20 |
| 10080196749188 | Medline | MEDLINE INDUSTRIES, INC. | 2021-01-19 |
| 20612479217946 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-07-09 |
| 20612479217922 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-07-09 |
| 10612479130002 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-16 |
| 10612479130033 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2020-06-16 |
| 10193489192018 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2020-04-23 |
| 00347682644703 | Medi-First Eye Pads | Medique Products | 2019-07-19 |
| 10885380054129 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-07-10 |
| 10686864050299 | AMD-RITMED | AMD Medicom Inc | 2019-01-14 |
| 10686864050282 | AMD-RITMED | AMD Medicom Inc | 2019-01-14 |
| 10884521722880 | Curity | Cardinal Health, Inc. | 2018-06-29 |
| 10884527021147 | Curity | Cardinal Health, Inc. | 2018-06-27 |
| 10884521553590 | Curity | Cardinal Health, Inc. | 2018-06-23 |