FDA product code HMP: Pad, Eye
HMP is the FDA product code for pad, eye. It is a Class I device, regulated under 21 CFR 878.4440 and reviewed by the General and Plastic Surgery panel. FDA has cleared 17 510(k) submissions under HMP, from 16 different applicants. The average 510(k) review took 54 days (median 55). FDA has posted 4 recalls for HMP devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Pad, Eye |
| Device class | Class I |
| Regulation | 21 CFR 878.4440 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HMP clearance
Top HMP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Keeler Instruments, Inc. | 2 | 1988-01-27 |
| Certified Safety Mfg., Inc. | 1 | 1994-03-07 |
| Deroyal Industries, Inc. | 1 | 1992-05-29 |
| Ulti-Med Intl., Inc. | 1 | 1990-12-05 |
| Consolidated Industries of Greater Syracuse, Inc. | 1 | 1988-11-22 |
11 more applicants have HMP clearances. See the full list in Caduvo.
Most recent HMP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K940333 | Certified Safety Mfg., Inc. | EYE PAD | 1994-03-07 | 41 |
| K921349 | Deroyal Industries, Inc. | STERILE,DISPOSABLE EYE DRESSING | 1992-05-29 | 71 |
| K904896 | Ulti-Med Intl., Inc. | EYE PAD | 1990-12-05 | 36 |
| K883822 | Consolidated Industries of Greater Syracuse, Inc. | FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309 | 1988-11-22 | 76 |
| K874411 | Keeler Instruments, Inc. | DONALDSON NATURAL EYEPATCH 'PATIENT PAK' | 1988-01-27 | 91 |
Recalls for HMP devices
4 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-11-15.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code HMP?
HMP is the FDA product code for pad, eye. It is a Class I device, regulated under 21 CFR 878.4440 and reviewed by the General and Plastic Surgery panel.
What device class is HMP?
Class I, regulation 21 CFR 878.4440. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HMP?
Across 17 cleared submissions the average was 54 days from receipt to decision (median 55).
Which companies have the most HMP clearances?
Keeler Instruments, Inc. (2); Certified Safety Mfg., Inc. (1); Deroyal Industries, Inc. (1); Ulti-Med Intl., Inc. (1); Consolidated Industries of Greater Syracuse, Inc. (1).
Have HMP devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2023-11-15.
Next steps
- Run an FDA pathway report with predicate devices for product code HMP
- Run a recall and safety report across every HMP manufacturer
- Watch product code HMP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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