FDA product code HMS: Drum, Eye Knife Test
HMS is the FDA product code for drum, eye knife test. It is a Class I device, regulated under 21 CFR 886.4230 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HMS. The average 510(k) review took 575 days (median 575).
Classification
| Field | Value |
|---|---|
| Device name | Drum, Eye Knife Test |
| Device class | Class I |
| Regulation | 21 CFR 886.4230 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HMS clearance
Top HMS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chiron Vision Corp. | 1 | 1994-07-19 |
Most recent HMS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K926412 | Chiron Vision Corp. | MICRON-SCOPE II | 1994-07-19 | 575 |
Recalls for HMS devices
openFDA lists no recalls for product code HMS.
Frequently asked questions
What is FDA product code HMS?
HMS is the FDA product code for drum, eye knife test. It is a Class I device, regulated under 21 CFR 886.4230 and reviewed by the Ophthalmic panel.
What device class is HMS?
Class I, regulation 21 CFR 886.4230. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HMS?
Across 1 cleared submissions the average was 575 days from receipt to decision (median 575).
Which companies have the most HMS clearances?
Chiron Vision Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HMS
- Run a recall and safety report across every HMS manufacturer
- Watch product code HMS 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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