FDA product code HRN: Unit, Cryophthalmic, Ac-Powered
HRN is the FDA product code for unit, cryophthalmic, ac-powered. It is a Class II device, regulated under 21 CFR 886.4170 and reviewed by the Ophthalmic panel. FDA has cleared 10 510(k) submissions under HRN, from 6 different applicants. The average 510(k) review took 126 days (median 96).
Classification
| Field | Value |
|---|---|
| Device name | Unit, Cryophthalmic, Ac-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.4170 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for HRN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 272 |
| 2018 | 1 | 51 |
| 2020 | 1 | 57 |
Compare with all 510(k) review times · Search every HRN clearance
Top HRN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Phakos | 3 | 2020-06-02 |
| Keeler Instruments, Inc. | 3 | 2011-12-08 |
| Dutch Ophthalmic Research Center International BV | 1 | 2017-01-23 |
| Keeler, Ltd. | 1 | 2013-12-23 |
| Dutch Ophthalmic USA, Inc. | 1 | 2001-10-22 |
1 more applicants have HRN clearances. See the full list in Caduvo.
Most recent HRN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K200911 | Phakos | MIRA Adapter | 2020-06-02 | 57 |
| K180195 | Phakos | Frigitronics adapter | 2018-03-16 | 51 |
| K162756 | Phakos | PHAKOS Disposable Retinal Cryo Probe | 2017-05-03 | 215 |
| K160591 | Dutch Ophthalmic Research Center International BV | D.O.R.C. Disposable Cryo Probe | 2017-01-23 | 328 |
| K131787 | Keeler, Ltd. | CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES | 2013-12-23 | 188 |
Recalls for HRN devices
openFDA lists no recalls for product code HRN.
Frequently asked questions
What is FDA product code HRN?
HRN is the FDA product code for unit, cryophthalmic, ac-powered. It is a Class II device, regulated under 21 CFR 886.4170 and reviewed by the Ophthalmic panel.
What device class is HRN?
Class II, regulation 21 CFR 886.4170. Typical premarket route: 510(k).
How long does a 510(k) take for product code HRN?
Across 10 cleared submissions the average was 126 days from receipt to decision (median 96).
Which companies have the most HRN clearances?
Phakos (3); Keeler Instruments, Inc. (3); Dutch Ophthalmic Research Center International BV (1); Keeler, Ltd. (1); Dutch Ophthalmic USA, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HRN
- Run a recall and safety report across every HRN manufacturer
- Watch product code HRN 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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