FDA product code HMW: Drape, Microscope, Ophthalmic
HMW is the FDA product code for drape, microscope, ophthalmic. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel. FDA has cleared 4 510(k) submissions under HMW, from 4 different applicants. The average 510(k) review took 68 days (median 80).
Classification
| Field | Value |
|---|---|
| Device name | Drape, Microscope, Ophthalmic |
| Device class | Class II |
| Regulation | 21 CFR 878.4370 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HMW clearance
Top HMW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Invotec International, Inc. | 1 | 1991-06-03 |
| North American Sterilization & Packaging Co. | 1 | 1990-09-20 |
| Medical Technique Instruments, Inc. | 1 | 1990-09-10 |
| Lifestream Int'L, Inc. | 1 | 1984-10-26 |
Most recent HMW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K911040 | Invotec International, Inc. | INVOTEC MICROSCOPE DRAPE | 1991-06-03 | 87 |
| K902763 | North American Sterilization & Packaging Co. | STERILE INSTRUMENT DRAPE | 1990-09-20 | 87 |
| K902851 | Medical Technique Instruments, Inc. | MICROSCOPE DRAPE | 1990-09-10 | 73 |
| K843890 | Lifestream Int'L, Inc. | CUSTOM INSTRUMENT DRAPE | 1984-10-26 | 24 |
Recalls for HMW devices
openFDA lists no recalls for product code HMW.
Frequently asked questions
What is FDA product code HMW?
HMW is the FDA product code for drape, microscope, ophthalmic. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel.
What device class is HMW?
Class II, regulation 21 CFR 878.4370. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HMW?
Across 4 cleared submissions the average was 68 days from receipt to decision (median 80).
Which companies have the most HMW clearances?
Invotec International, Inc. (1); North American Sterilization & Packaging Co. (1); Medical Technique Instruments, Inc. (1); Lifestream Int'L, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HMW
- Run a recall and safety report across every HMW manufacturer
- Watch product code HMW 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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