Lake Region Mfg., Inc.: FDA clearances and approvals
Lake Region Mfg., Inc. has 42 FDA 510(k) clearances (first 1977, latest 2010), across 8 product codes in 3 review panels. Median 510(k) review time: 70 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 31 | 31 |
| DQY | Catheter, Percutaneous | 3 | 3 |
| KNY | Accessories, Catheter, G-U | 3 | 3 |
| EZB | Stylet For Catheter, Gastro-Urology | 1 | 1 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 1 | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| OCY | Endoscopic Guidewire, Gastroenterology-Urology | 1 | 1 |
Review panels
- Cardiovascular (34)
- Gastroenterology and Urology (7)
- Orthopedic (1)
Most recent Lake Region Mfg., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K092965 | TRAILRUNNER GUIDEWIRES | DQX | 2010-02-26 | 154 |
| K082922 | FREEWAY AND RAILRUNNER GUIDEWIRES | DQX | 2008-12-09 | 69 |
| K081708 | TAXI ENDOSCOPIC GUIDEWIRE | OCY | 2008-08-26 | 70 |
| K080144 | MANDREL GUIDEWIRES OR M-WIRES | DQX | 2008-02-26 | 35 |
| K073655 | PEGASUS STEERABLE (PTCA) GUIDEWIRE | DQX | 2008-01-28 | 33 |
| K060454 | TITAN GUIDEWIRE | DQX | 2006-03-24 | 30 |
| K052347 | TITAN STEERABLE (PTCA) GUIDEWIRE | DQX | 2006-02-17 | 172 |
| K042338 | CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE | DQX | 2004-09-16 | 17 |
| K041624 | PTCA STEERABLE HYDROPHILIC GUIDEWIRE | DQX | 2004-07-16 | 30 |
| K040825 | LAKE REGION HYDROPHILIC GUIDEWIRE | DQX | 2004-05-17 | 48 |
32 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lake Region Mfg., 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.
Frequently asked questions
How many FDA 510(k) clearances does Lake Region Mfg., Inc. have?
Lake Region Mfg., Inc. has 42 FDA 510(k) clearances (first 1977, latest 2010), across 8 product codes in 3 review panels.
How long does FDA take to clear Lake Region Mfg., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Lake Region Mfg., Inc.'s cleared 510(k)s is 70 days.
What devices does Lake Region Mfg., Inc. make?
Its most frequent FDA product codes are DQX (Wire, Guide, Catheter, 31); DQY (Catheter, Percutaneous, 3); KNY (Accessories, Catheter, G-U, 3).
Has Lake Region Mfg., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Lake Region Mfg., Inc. Related entities may recall under other names.
Next steps
- See all 42 Lake Region Mfg., Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Lake Region Mfg., 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.