Ocular Therapeutix, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Ocular Therapeutix, Inc.” (first 2013, latest 2013), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 94 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 94 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HKY | Tonometer, Manual | 1 | 1 |
| PFZ | Ophthalmic Sealant | 1 | 0 |
Review panels
- Ophthalmic (2)
Most recent Ocular Therapeutix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132917 | OCULAR FORCE GAUGE | HKY | 2013-12-20 | 94 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P130004 | PMA | RESURE SEALANT | 2014-01-08 |
Recalls
openFDA lists no recalls under a recalling firm named Ocular Therapeutix, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Ocular Therapeutix, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04050865: A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis (Completed, started 2019-08-05)
- NCT02310815: ReSure Sealant Post Approval Study (Completed, started 2014-12)
- NCT01498224: ReSure Sealant Pivotal Study (Completed, started 2011-12)
- NCT00774228: I-ZIP Ocular Bandage Pivotal Study (Completed, started 2008-10)
SEC filings
OCULAR THERAPEUTIX, INC (OCUL): EDGAR filings, CIK 1393434. An SEC registrant with the same name, matched by name only.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ocular Instruments, Inc. (50 510(k)s)
- Ocular Sciences Puerto Rico, Inc. (7 510(k)s)
- Ocular Blood Flow Laboratories, Inc. (2 510(k)s)
- Ocular Innovations, Inc. (2 510(k)s)
- Ocular Sciences, Inc. (2 510(k)s)
- Ocular Concepts, LLC (1 510(k)s)
- Ocular Pharmaceuticals, Inc. (1 510(k)s)
- Ocular Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ocular Therapeutix, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Ocular Therapeutix, Inc.” (first 2013, latest 2013), plus 1 PMA decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ocular Therapeutix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ocular Therapeutix, Inc. is 94 days.
Which FDA product codes appear under Ocular Therapeutix, Inc.?
The most frequent FDA product codes under this applicant name are HKY (Tonometer, Manual, 1); PFZ (Ophthalmic Sealant, 1).
Next steps
- See all 1 Ocular Therapeutix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HKY, Ocular Therapeutix, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.