FDA product code HKS: Prism, Gonioscopic
HKS is the FDA product code for prism, gonioscopic. It is a Class I device, regulated under 21 CFR 886.1660 and reviewed by the Ophthalmic panel. FDA has cleared 10 510(k) submissions under HKS, from 4 different applicants. The average 510(k) review took 58 days (median 46). FDA has posted 1 recall for HKS devices.
Classification
| Field | Value |
|---|---|
| Device name | Prism, Gonioscopic |
| Device class | Class I |
| Regulation | 21 CFR 886.1660 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HKS clearance
Top HKS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ocular Instruments, Inc. | 7 | 1994-04-01 |
| Sensor Medical Technology, LLC | 1 | 2014-04-29 |
| Keta Corp. | 1 | 1986-05-06 |
| Jedmed Instrument Co. | 1 | 1983-02-07 |
Most recent HKS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140368 | Sensor Medical Technology, LLC | FAMILY OF DISPOSABLE LENSES | 2014-04-29 | 74 |
| K935302 | Ocular Instruments, Inc. | OSHER SURGICAL GONIO/POSTERIOR POLE LENS | 1994-04-01 | 150 |
| K895846 | Ocular Instruments, Inc. | TWO MIRROR GONIO LENS | 1989-12-18 | 76 |
| K890977 | Ocular Instruments, Inc. | MCINTYRE SURGICAL GONIOLENS | 1989-05-23 | 85 |
| K862692 | Ocular Instruments, Inc. | KARICKHOFF DIAGNOSTIC/LASER LENS | 1986-08-21 | 37 |
Recalls for HKS devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-06-30.
Frequently asked questions
What is FDA product code HKS?
HKS is the FDA product code for prism, gonioscopic. It is a Class I device, regulated under 21 CFR 886.1660 and reviewed by the Ophthalmic panel.
What device class is HKS?
Class I, regulation 21 CFR 886.1660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HKS?
Across 10 cleared submissions the average was 58 days from receipt to decision (median 46).
Which companies have the most HKS clearances?
Ocular Instruments, Inc. (7); Sensor Medical Technology, LLC (1); Keta Corp. (1); Jedmed Instrument Co. (1).
Have HKS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-06-30.
Next steps
- Run an FDA pathway report with predicate devices for product code HKS
- Run a recall and safety report across every HKS manufacturer
- Watch product code HKS 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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