Lake Region Medical: FDA clearances and approvals
Lake Region Medical has 17 FDA 510(k) clearances (first 2008, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time: 88 days. Since 2017 its median was 121 days, against 134 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 2 | 106 |
| 2014 | 6 | 66 |
| 2015 | 1 | 31 |
| 2016 | 1 | 225 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 168 |
| 2022 | 1 | 128 |
| 2023 | 0 | — |
| 2024 | 1 | 79 |
| 2025 | 0 | — |
| 2026 | 1 | 114 |
Review time against the same product codes
Since 2017, Lake Region Medical's cleared 510(k)s took a median 121 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 134 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 13 | 13 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | 4 | 4 |
Review panels
Most recent Lake Region Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253746 | Enroute 0.014'' Transcarotid Guidewire | DQX | 2026-03-19 | 114 |
| K242824 | PTFE Guidewire | DQX | 2024-12-06 | 79 |
| K221575 | Pre-Formed Blue | DQX | 2022-10-07 | 128 |
| K211741 | Pre-Formed Extra Support Guidewire | DQX | 2021-11-22 | 168 |
| K160643 | ENROUTE 0.014 Guidewire | DQX | 2016-10-18 | 225 |
| K151244 | Pre-Formed Guidewire | DQX | 2015-06-11 | 31 |
| K140536 | HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE | DQX | 2014-12-17 | 288 |
| K142393 | PREDICATE III GUIDEWIRE | DQX | 2014-11-25 | 90 |
| K142397 | Predicate III Guidewire | OCY | 2014-09-19 | 23 |
| K140482 | MANDREL GUIDEWIRE | OCY | 2014-04-08 | 41 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lake Region Medical.
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 Lake Region Medical have?
Lake Region Medical has 17 FDA 510(k) clearances (first 2008, latest 2026), across 2 product codes in 2 review panels.
How long does FDA take to clear Lake Region Medical's 510(k)s?
The median time from FDA receipt to decision across Lake Region Medical's cleared 510(k)s is 88 days. Since 2017: 121 days, versus 134 days for all cleared 510(k)s in the same product codes.
What devices does Lake Region Medical make?
Its most frequent FDA product codes are DQX (Wire, Guide, Catheter, 13); OCY (Endoscopic Guidewire, Gastroenterology-Urology, 4).
Has Lake Region Medical had device recalls?
openFDA lists no recalls under a recalling firm name matching Lake Region Medical. Related entities may recall under other names.
Next steps
- See all 17 Lake Region Medical clearances with predicates and recalls
- Run predicate analysis for product code DQX, Lake Region Medical'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.