Optim, LLC: FDA clearances and approvals
Optim, LLC has 6 FDA 510(k) clearances (first 2008, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time: 46 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 20 |
| 2013 | 1 | 53 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 310 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 143 |
Review time against the same product codes
Since 2017, Optim, LLC's cleared 510(k)s took a median 226 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 186 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 3 | 3 |
| FEH | Electrode, Flexible Suction Coagulator | 2 | 2 |
| NTN | Led Light Source | 1 | 1 |
Review panels
Most recent Optim, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254133 | ENTity USB Videoscope System | EOB | 2026-05-14 | 143 |
| K200609 | ENTity WiFi Video Nasopharyngoscope System | EOB | 2021-01-13 | 310 |
| K130489 | ELECTRODE, FLEXIBLE SUCTION COAGULATOR | FEH | 2013-04-19 | 53 |
| K122593 | PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 | FEH | 2012-09-13 | 20 |
| K091829 | PLS PORTABLE LIGHT SOURCE | NTN | 2009-07-28 | 39 |
| K080622 | ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 | EOB | 2008-04-02 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Optim, LLC.
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 Optim, LLC have?
Optim, LLC has 6 FDA 510(k) clearances (first 2008, latest 2026), across 3 product codes in 2 review panels.
How long does FDA take to clear Optim, LLC's 510(k)s?
The median time from FDA receipt to decision across Optim, LLC's cleared 510(k)s is 46 days.
What devices does Optim, LLC make?
Its most frequent FDA product codes are EOB (Nasopharyngoscope (Flexible Or Rigid), 3); FEH (Electrode, Flexible Suction Coagulator, 2); NTN (Led Light Source, 1).
Has Optim, LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching Optim, LLC. Related entities may recall under other names.
Next steps
- See all 6 Optim, LLC clearances with predicates and recalls
- Run predicate analysis for product code EOB, Optim, LLC'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.