FDA product code HKP: Instrument, Vitreous Aspiration And Cutting, Battery-Powered
HKP is the FDA product code for instrument, vitreous aspiration and cutting, battery-powered. It is a Class II device, regulated under 21 CFR 886.4150 and reviewed by the Ophthalmic panel. FDA has cleared 16 510(k) submissions under HKP, from 13 different applicants. The average 510(k) review took 107 days (median 62).
Classification
| Field | Value |
|---|---|
| Device name | Instrument, Vitreous Aspiration And Cutting, Battery-Powered |
| Device class | Class II |
| Regulation | 21 CFR 886.4150 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top HKP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Varian Assoc., Inc. | 3 | 1979-08-28 |
| Concept, Inc. | 2 | 1979-09-04 |
| Aaron Medical Industries | 1 | 1997-03-19 |
| Grieshaber & Co. | 1 | 1995-05-05 |
| Medical Instrument Development Laboratories, Inc. | 1 | 1995-04-10 |
8 more applicants have HKP clearances. See the full list in Caduvo.
Most recent HKP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952558 | Aaron Medical Industries | AARON VAC 2 | 1997-03-19 | 656 |
| K950056 | Grieshaber & Co. | THE GRIESHABER AXIAL CUTTER | 1995-05-05 | 119 |
| K950287 | Medical Instrument Development Laboratories, Inc. | UNIVIT PROBE | 1995-04-10 | 76 |
| K896622 | Visitec Co. | VISITEC VITRECTOMY UNIT | 1990-04-04 | 134 |
| K890595 | Mentor O & O, Inc. | MENTOR ANTERIOR SEGMENT VITRECTOR | 1989-04-17 | 70 |
Recalls for HKP devices
openFDA lists no recalls for product code HKP.
Frequently asked questions
What is FDA product code HKP?
HKP is the FDA product code for instrument, vitreous aspiration and cutting, battery-powered. It is a Class II device, regulated under 21 CFR 886.4150 and reviewed by the Ophthalmic panel.
What device class is HKP?
Class II, regulation 21 CFR 886.4150. Typical premarket route: 510(k).
How long does a 510(k) take for product code HKP?
Across 16 cleared submissions the average was 107 days from receipt to decision (median 62).
Which companies have the most HKP clearances?
Varian Assoc., Inc. (3); Concept, Inc. (2); Aaron Medical Industries (1); Grieshaber & Co. (1); Medical Instrument Development Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HKP
- Run a recall and safety report across every HKP manufacturer
- Watch product code HKP 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.