FDA product code HMY: Keratome, Battery-Powered
HMY is the FDA product code for keratome, battery-powered. It is a Class I device, regulated under 21 CFR 886.4370 and reviewed by the Ophthalmic panel. FDA has cleared 12 510(k) submissions under HMY, from 7 different applicants. The average 510(k) review took 68 days (median 62). FDA has posted 2 recalls for HMY devices.
Classification
| Field | Value |
|---|---|
| Device name | Keratome, Battery-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.4370 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HMY clearance
Top HMY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Moria, Inc. | 3 | 2001-03-09 |
| Moria SA | 2 | 2004-03-31 |
| Becton, Dickinson & CO | 2 | 2002-10-18 |
| Insight Technologies Instruments, LLC | 2 | 1999-05-14 |
| Industrial & Medical Design, Inc. | 1 | 1999-09-24 |
2 more applicants have HMY clearances. See the full list in Caduvo.
Most recent HMY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K040297 | Moria SA | ONEUSE- PLUS MICROKERATOME | 2004-03-31 | 51 |
| K023092 | Becton, Dickinson & CO | BD K-4000 MICROKERATOME SYSTEM | 2002-10-18 | 30 |
| K022637 | Becton, Dickinson & CO | BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME | 2002-10-16 | 69 |
| K022560 | Moria SA | M2 SINGLE USE MICROKERTOME | 2002-09-27 | 56 |
| K003594 | Moria, Inc. | CARRIAZO BARRAQUER SINGLE USE MICROKERATOME | 2001-03-09 | 108 |
Recalls for HMY devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-08-09.
Frequently asked questions
What is FDA product code HMY?
HMY is the FDA product code for keratome, battery-powered. It is a Class I device, regulated under 21 CFR 886.4370 and reviewed by the Ophthalmic panel.
What device class is HMY?
Class I, regulation 21 CFR 886.4370. Typical premarket route: 510(k).
How long does a 510(k) take for product code HMY?
Across 12 cleared submissions the average was 68 days from receipt to decision (median 62).
Which companies have the most HMY clearances?
Moria, Inc. (3); Moria SA (2); Becton, Dickinson & CO (2); Insight Technologies Instruments, LLC (2); Industrial & Medical Design, Inc. (1).
Have HMY devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2007-08-09.
Next steps
- Run an FDA pathway report with predicate devices for product code HMY
- Run a recall and safety report across every HMY manufacturer
- Watch product code HMY 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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