FDA product code HMT: Drape, Patient, Ophthalmic
HMT is the FDA product code for drape, patient, ophthalmic. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel. FDA has cleared 7 510(k) submissions under HMT, from 7 different applicants. The average 510(k) review took 49 days (median 44). FDA has posted 1 recall for HMT devices.
Classification
| Field | Value |
|---|---|
| Device name | Drape, Patient, 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 HMT clearance
Top HMT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Visitec Co. | 1 | 1995-02-14 |
| Angiosystems, Inc. | 1 | 1991-02-06 |
| Solos Ophthalmology | 1 | 1987-07-31 |
| Treace Medical, Inc. | 1 | 1987-05-18 |
| Charles Atkins & Co. | 1 | 1986-02-13 |
2 more applicants have HMT clearances. See the full list in Caduvo.
Most recent HMT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K945738 | Visitec Co. | VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE | 1995-02-14 | 83 |
| K905460 | Angiosystems, Inc. | STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY | 1991-02-06 | 63 |
| K872620 | Solos Ophthalmology | SOLOS EYESITE DRAPES | 1987-07-31 | 25 |
| K871706 | Treace Medical, Inc. | OPTHA PREP | 1987-05-18 | 17 |
| K854613 | Charles Atkins & Co. | SURGICAL DRAPES, OPHTHALMIN | 1986-02-13 | 87 |
Recalls for HMT devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-06-03.
Frequently asked questions
What is FDA product code HMT?
HMT is the FDA product code for drape, patient, ophthalmic. It is a Class II device, regulated under 21 CFR 878.4370 and reviewed by the General Hospital panel.
What device class is HMT?
Class II, regulation 21 CFR 878.4370. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HMT?
Across 7 cleared submissions the average was 49 days from receipt to decision (median 44).
Which companies have the most HMT clearances?
Visitec Co. (1); Angiosystems, Inc. (1); Solos Ophthalmology (1); Treace Medical, Inc. (1); Charles Atkins & Co. (1).
Have HMT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-06-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HMT
- Run a recall and safety report across every HMT manufacturer
- Watch product code HMT 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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