FDA product code HRH: Trephine, Manual, Ophthalmic
HRH is the FDA product code for trephine, manual, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel. FDA has cleared 12 510(k) submissions under HRH, from 10 different applicants. The average 510(k) review took 79 days (median 38). FDA has posted 1 recall for HRH devices.
Classification
| Field | Value |
|---|---|
| Device name | Trephine, Manual, Ophthalmic |
| Device class | Class I |
| Regulation | 21 CFR 886.4350 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HRH clearance
Top HRH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Precision Instruments, Inc. | 3 | 1987-01-20 |
| Stephens Instruments | 1 | 2002-11-01 |
| Intramed Laboratories, Inc. | 1 | 1994-06-13 |
| Richmond Products, Inc. | 1 | 1987-10-28 |
| Deknatel, Inc. | 1 | 1986-08-11 |
5 more applicants have HRH clearances. See the full list in Caduvo.
Most recent HRH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022843 | Stephens Instruments | GAYHEART CORNEAL EXCISION DEVICE | 2002-11-01 | 66 |
| K931792 | Intramed Laboratories, Inc. | ARTHROSCOPE | 1994-06-13 | 427 |
| K873918 | Richmond Products, Inc. | HEAD & CHIN RESTS | 1987-10-28 | 34 |
| K864520 | Precision Instruments, Inc. | BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON | 1987-01-20 | 64 |
| K862524 | Deknatel, Inc. | DEKNATEL (R) TREPHINE | 1986-08-11 | 40 |
Recalls for HRH devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-05-03.
Frequently asked questions
What is FDA product code HRH?
HRH is the FDA product code for trephine, manual, ophthalmic. It is a Class I device, regulated under 21 CFR 886.4350 and reviewed by the Ophthalmic panel.
What device class is HRH?
Class I, regulation 21 CFR 886.4350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HRH?
Across 12 cleared submissions the average was 79 days from receipt to decision (median 38).
Which companies have the most HRH clearances?
Precision Instruments, Inc. (3); Stephens Instruments (1); Intramed Laboratories, Inc. (1); Richmond Products, Inc. (1); Deknatel, Inc. (1).
Have HRH devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-05-03.
Next steps
- Run an FDA pathway report with predicate devices for product code HRH
- Run a recall and safety report across every HRH manufacturer
- Watch product code HRH 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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