FDA product code HMR: Marker, Ocular
HMR is the FDA product code for marker, ocular. It is a Class I device, regulated under 21 CFR 886.4570 and reviewed by the Ophthalmic panel. FDA has cleared 5 510(k) submissions under HMR, from 5 different applicants. The average 510(k) review took 169 days (median 53). FDA has posted 6 recalls for HMR devices.
Classification
| Field | Value |
|---|---|
| Device name | Marker, Ocular |
| Device class | Class I |
| Regulation | 21 CFR 886.4570 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HMR clearance
Top HMR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Refractec, Inc. | 1 | 2006-03-03 |
| Chiron Vision Corp. | 1 | 1994-08-29 |
| Innomed Corp. | 1 | 1987-09-04 |
| Myocure, Inc. | 1 | 1986-10-20 |
| CooperVision, Inc. | 1 | 1986-05-14 |
Most recent HMR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K053475 | Refractec, Inc. | OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450 | 2006-03-03 | 79 |
| K925606 | Chiron Vision Corp. | OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS | 1994-08-29 | 662 |
| K872747 | Innomed Corp. | LASER CENTERING DEVICE | 1987-09-04 | 53 |
| K863663 | Myocure, Inc. | OPHTHALMIC SURGICAL OCULAR MARKERS | 1986-10-20 | 32 |
| K861535 | CooperVision, Inc. | OPTICAL MARKERS/FIXATION RING/CANNU & IRRIGA CANNU | 1986-05-14 | 20 |
Recalls for HMR devices
6 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-12-23.
Frequently asked questions
What is FDA product code HMR?
HMR is the FDA product code for marker, ocular. It is a Class I device, regulated under 21 CFR 886.4570 and reviewed by the Ophthalmic panel.
What device class is HMR?
Class I, regulation 21 CFR 886.4570. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HMR?
Across 5 cleared submissions the average was 169 days from receipt to decision (median 53).
Which companies have the most HMR clearances?
Refractec, Inc. (1); Chiron Vision Corp. (1); Innomed Corp. (1); Myocure, Inc. (1); CooperVision, Inc. (1).
Have HMR devices been recalled?
Yes: 6 product recalls across 1 recall events; the most recent began 2010-12-23.
Next steps
- Run an FDA pathway report with predicate devices for product code HMR
- Run a recall and safety report across every HMR manufacturer
- Watch product code HMR 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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