Acuity Polymers, Inc.: FDA clearances and approvals
Acuity Polymers, Inc. has 11 FDA 510(k) clearances (first 2016, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time: 80 days. Since 2017 its median was 76 days, against 76 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 141 |
| 2017 | 3 | 148 |
| 2018 | 1 | 53 |
| 2019 | 0 | — |
| 2020 | 1 | 127 |
| 2021 | 2 | 88 |
| 2022 | 0 | — |
| 2023 | 1 | 72 |
| 2024 | 2 | 54 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Acuity Polymers, Inc.'s cleared 510(k)s took a median 76 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 76 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQD | Lens, Contact (Other Material) - Daily | 11 | 11 |
Review panels
- Ophthalmic (11)
Most recent Acuity Polymers, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242393 | Acuity 181 (tisilfocon A) and Acuity 181 (tisilfocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lenses | HQD | 2024-11-01 | 80 |
| K240618 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200 with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100 with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens | HQD | 2024-04-03 | 29 |
| K230965 | Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lens | HQD | 2023-06-16 | 72 |
| K213538 | Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | HQD | 2021-12-30 | 52 |
| K203571 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | HQD | 2021-04-09 | 123 |
| K201194 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | HQD | 2020-09-08 | 127 |
| K180988 | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens | HQD | 2018-06-08 | 53 |
| K170001 | Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens | HQD | 2017-06-02 | 150 |
| K170007 | Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens | HQD | 2017-05-31 | 148 |
| K163254 | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens | HQD | 2017-01-18 | 58 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Acuity Polymers, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Acuity Polymers, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06009458: Acuity 200™ (Fluoroxyfocon A) Orthokeratology Contact Lens for Overnight Wear (Active not recruiting, started 2023-10-01)
- NCT03971227: Clinical Evaluation of Acuity 200 (Fluoroxyfocon A) RGP Contact Lens (Completed, started 2019-04-01)
Frequently asked questions
How many FDA 510(k) clearances does Acuity Polymers, Inc. have?
Acuity Polymers, Inc. has 11 FDA 510(k) clearances (first 2016, latest 2024), across 1 product code in 1 review panel.
How long does FDA take to clear Acuity Polymers, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Acuity Polymers, Inc.'s cleared 510(k)s is 80 days. Since 2017: 76 days, versus 76 days for all cleared 510(k)s in the same product codes.
What devices does Acuity Polymers, Inc. make?
Its most frequent FDA product codes are HQD (Lens, Contact (Other Material) - Daily, 11).
Has Acuity Polymers, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Acuity Polymers, Inc. Related entities may recall under other names.
Next steps
- See all 11 Acuity Polymers, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQD, Acuity Polymers, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.