FDA product code HPX: Lens, Contact (Polymethylmethacrylate)
HPX is the FDA product code for lens, contact (polymethylmethacrylate). It is a Unclassified device, reviewed by the Ophthalmic panel. FDA has cleared 74 510(k) submissions under HPX, from 45 different applicants. The average 510(k) review took 77 days (median 48). 13 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Contact (Polymethylmethacrylate) |
| Device class | Unclassified |
| Review panel | OP — Ophthalmic |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every HPX clearance
Top HPX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Allergan, Inc. | 8 | 1986-06-02 |
| Maurry Biological Co. | 6 | 1986-05-29 |
| Bausch & Lomb, Inc. | 5 | 1986-04-04 |
| Optacryl, Inc. | 4 | 1982-05-05 |
| Paco Pharmaceutical Services, Inc. | 3 | 1987-01-20 |
40 more applicants have HPX clearances. See the full list in Caduvo.
Most recent HPX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K955777 | Rand Scientific Corp. | PMMA CLASIC | 1996-05-16 | 148 |
| K940106 | Visionary Technologies of Miami, Inc. | KERATOPLASTY SUTURING LENS | 1994-05-25 | 135 |
| K913081 | Camp Contact Lenses | MULTI-VIEW BIFOCALS | 1991-10-23 | 107 |
| K897021 | Bruce W. Martin O.D. and Edward Hensley | MARTIN-HENSLEY SEGMENT LENS | 1990-06-22 | 185 |
| K895411 | Optikem Polymers, Inc. | OPTIKEM PMMA CONTACT LENS | 1990-02-27 | 174 |
Recalls for HPX devices
openFDA lists no recalls for product code HPX.
Frequently asked questions
What is FDA product code HPX?
HPX is the FDA product code for lens, contact (polymethylmethacrylate). It is a Unclassified device, reviewed by the Ophthalmic panel.
What device class is HPX?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code HPX?
Across 74 cleared submissions the average was 77 days from receipt to decision (median 48).
Which companies have the most HPX clearances?
Allergan, Inc. (8); Maurry Biological Co. (6); Bausch & Lomb, Inc. (5); Optacryl, Inc. (4); Paco Pharmaceutical Services, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code HPX
- Run a recall and safety report across every HPX manufacturer
- Watch product code HPX 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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