Oasis Medical, Inc.: FDA clearances and approvals
Oasis Medical, Inc. has 17 FDA 510(k) clearances (first 1991, latest 2022), across 7 product codes in 1 review panel. Median 510(k) review time: 90 days. openFDA lists 44 product recalls by a recalling firm named Oasis Medical, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 237 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 165 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Oasis Medical, Inc.'s cleared 510(k)s took a median 201 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 174 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZU | Plug, Punctum | 6 | 6 |
| HNO | Keratome, Ac-Powered | 5 | 5 |
| HQC | Unit, Phacofragmentation | 2 | 2 |
| HKY | Tonometer, Manual | 1 | 1 |
| HOZ | Sponge, Ophthalmic | 1 | 1 |
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | 1 | 1 |
| MOE | Collagen Corneal Shield | 1 | 1 |
Review panels
- Ophthalmic (17)
Most recent Oasis Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213988 | SOFT PLUG Extended Duration 180 Tapered Canalicular Plug | LZU | 2022-06-03 | 165 |
| K162361 | Soft Plug Extended Duration 180 Canalicular Plug | LZU | 2017-04-17 | 237 |
| K032297 | DISPOSABLE N-PE MICKROKERATOME BLADES | HNO | 2003-08-26 | 32 |
| K030401 | DISPOSABLE M2-PE MICROKERATOME BLADES | HNO | 2003-06-19 | 133 |
| K022205 | DISPOSABLE N-PE MICROKERATOME BLADES | HNO | 2002-10-03 | 90 |
| K013613 | SOFT PLUG ABSORBABLE PLUG-SA | LZU | 2002-06-27 | 234 |
| K003820 | DISPOSABLE CB-PE MICROKERATOME BLADES | HNO | 2001-03-08 | 87 |
| K001176 | DISPOSABLE MICROKERATOME BLADES-PE | HNO | 2000-09-21 | 163 |
| K980437 | SILICONE PUNCTAL PLUG | LZU | 1998-04-30 | 85 |
| K950798 | POSTERIOR CAPSULE SHIELD | HQC | 1995-05-22 | 90 |
7 earlier clearances. See the full list in Caduvo.
Recalls
44 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2007-07-18.
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.
Frequently asked questions
How many FDA 510(k) clearances does Oasis Medical, Inc. have?
Oasis Medical, Inc. has 17 FDA 510(k) clearances (first 1991, latest 2022), across 7 product codes in 1 review panel.
How long does FDA take to clear Oasis Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Oasis Medical, Inc.'s cleared 510(k)s is 90 days.
What devices does Oasis Medical, Inc. make?
Its most frequent FDA product codes are LZU (Plug, Punctum, 6); HNO (Keratome, Ac-Powered, 5); HQC (Unit, Phacofragmentation, 2).
Has Oasis Medical, Inc. had device recalls?
openFDA lists 44 product recalls in 5 recall events by a recalling firm whose name matches Oasis Medical, Inc; the most recent began 2007-07-18. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 17 Oasis Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LZU, Oasis Medical, 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.