FDA product code HPT: Perimeter, Automatic, Ac-Powered
HPT is the FDA product code for perimeter, automatic, ac-powered. It is a Class I device, regulated under 21 CFR 886.1605 and reviewed by the Ophthalmic panel. FDA has cleared 41 510(k) submissions under HPT, from 30 different applicants. The average 510(k) review took 102 days (median 81). FDA has posted 1 recall for HPT devices.
Classification
| Field | Value |
|---|---|
| Device name | Perimeter, Automatic, Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 886.1605 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HPT clearance
Top HPT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Synemed, Inc. | 3 | 1995-11-17 |
| Bio-Rad | 3 | 1987-02-20 |
| Dicon, Inc. | 3 | 1982-09-30 |
| Kowa Optimed, Inc. | 2 | 1996-06-17 |
| Vismed, Inc. | 2 | 1993-10-18 |
25 more applicants have HPT clearances. See the full list in Caduvo.
Most recent HPT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K092187 | Centervue S.P.A. | MAIA, MODEL 1 | 2010-05-27 | 310 |
| K093213 | Carl Zeiss Meditec, Inc. | GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES | 2010-03-12 | 150 |
| K091579 | Notal Vision , Ltd. | FORESEE HOME | 2009-12-23 | 204 |
| K063310 | Seeing Machines Limited | TRUEFIELD ANALYZER | 2007-08-02 | 273 |
| K050350 | Notal Vision, Inc. | THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) | 2005-04-29 | 77 |
Recalls for HPT devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-08-17.
Frequently asked questions
What is FDA product code HPT?
HPT is the FDA product code for perimeter, automatic, ac-powered. It is a Class I device, regulated under 21 CFR 886.1605 and reviewed by the Ophthalmic panel.
What device class is HPT?
Class I, regulation 21 CFR 886.1605. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HPT?
Across 41 cleared submissions the average was 102 days from receipt to decision (median 81).
Which companies have the most HPT clearances?
Synemed, Inc. (3); Bio-Rad (3); Dicon, Inc. (3); Kowa Optimed, Inc. (2); Vismed, Inc. (2).
Have HPT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2012-08-17.
Next steps
- Run an FDA pathway report with predicate devices for product code HPT
- Run a recall and safety report across every HPT manufacturer
- Watch product code HPT 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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