Drape, Patient, Ophthalmic
The Ophthalmic Patient Drape is a sterile surgical drape used to cover and isolate the patient's face and eye area during ophthalmic surgical procedures, maintaining a sterile field and reducing the risk of infection. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is HMT, regulated under 21 CFR 878.4370, within the General and Plastic Surgery medical specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HMT
- Device Class
- FDA class 2
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K945738 | VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE | Feb 14, 1995 | Substantially Equivalent | Visitec Co. |
| K905460 | STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY | Feb 06, 1991 | Substantially Equivalent | Angiosystems, Inc. |
| K872620 | SOLOS EYESITE DRAPES | Jul 31, 1987 | Substantially Equivalent | Solos Ophthalmology |
| K871706 | OPTHA PREP | May 18, 1987 | Substantially Equivalent | Treace Medical, Inc. |
| K854613 | SURGICAL DRAPES, OPHTHALMIN | Feb 13, 1986 | Substantially Equivalent | Charles Atkins & Co. |
| K831340 | DRAIN-R-DRAPE(EYE | Jun 08, 1983 | Substantially Equivalent | Sur-Tech, Inc. |
| K830822 | EYE DRAPE | Apr 06, 1983 | Substantially Equivalent | CooperVision, Inc. |
FEI Numbers
This FDA classification entry is associated with 47 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 47 registration numbers. Click on an entry to view related FDA registrations.