FDA product code HPS: Unit, Cryophthalmic
HPS is the FDA product code for unit, cryophthalmic. It is a Class II device, regulated under 21 CFR 886.4170 and reviewed by the Ophthalmic panel. FDA has cleared 11 510(k) submissions under HPS, from 10 different applicants. The average 510(k) review took 104 days (median 86). FDA has posted 4 recalls for HPS devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Unit, Cryophthalmic |
| 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 HPS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 160 |
Compare with all 510(k) review times · Search every HPS clearance
Top HPS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Keeler Instruments, Inc. | 2 | 1988-01-29 |
| VitreQ BV | 1 | 2020-12-30 |
| Dutch Ophthalmic USA, Inc. | 1 | 1994-07-18 |
| Mira, Inc. | 1 | 1992-10-19 |
| Spembly Medical , Ltd. | 1 | 1990-10-11 |
5 more applicants have HPS clearances. See the full list in Caduvo.
Most recent HPS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K202038 | VitreQ BV | CryoTreQ | 2020-12-30 | 160 |
| K940373 | Dutch Ophthalmic USA, Inc. | OPHTHALMIC CRYO UNIT | 1994-07-18 | 173 |
| K923629 | Mira, Inc. | OPHTHALMIC TRICHIASIS PROBE | 1992-10-19 | 90 |
| K903303 | Spembly Medical , Ltd. | SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES | 1990-10-11 | 79 |
| K874555 | Keeler Instruments, Inc. | KEELER ACU 22XT OPHTHALMIC CRYO UNIT | 1988-01-29 | 86 |
Recalls for HPS devices
4 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-03-17.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code HPS?
HPS is the FDA product code for unit, cryophthalmic. It is a Class II device, regulated under 21 CFR 886.4170 and reviewed by the Ophthalmic panel.
What device class is HPS?
Class II, regulation 21 CFR 886.4170. Typical premarket route: 510(k).
How long does a 510(k) take for product code HPS?
Across 11 cleared submissions the average was 104 days from receipt to decision (median 86).
Which companies have the most HPS clearances?
Keeler Instruments, Inc. (2); VitreQ BV (1); Dutch Ophthalmic USA, Inc. (1); Mira, Inc. (1); Spembly Medical , Ltd. (1).
Have HPS devices been recalled?
Yes: 4 product recalls across 2 recall events; the most recent began 2023-03-17.
Next steps
- Run an FDA pathway report with predicate devices for product code HPS
- Run a recall and safety report across every HPS manufacturer
- Watch product code HPS 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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