# Lake Region Medical

- Location (FDA's records): Chaska, MN
- FDA decisions: 17 (2008–2026): 17 510(k) clearances
- Names in FDA's records: Lake Region Medical (16); Lake Region Medical, Inc. (1)
- Product codes: DQX (13), OCY (4)
- 510(k) review time since 2016: median 128 days, against 161 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 25 (8 its own); citations of its devices by later devices: 15 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Lake Region Mfg., Inc.: 10 (https://510kreport.com/company/lake-region-mfg)
- Asahi Intecc Co., Ltd.: 2 (https://510kreport.com/company/asahi-intecc)
- Brivant, Ltd.: 1 (https://510kreport.com/company/brivant)
- Ev3, Inc.: 1 (https://510kreport.com/company/ev3)
- Toray Industries (America), Inc.: 1 (https://510kreport.com/company/toray-industries-america)
- Boston Scientific Corp: 1 (https://510kreport.com/company/boston-scientific)
- Meadox Medicals, Div. Boston Scientific Corp.: 1 (https://510kreport.com/company/meadox-medicals-div-boston-scientific)

## Firms that cite its devices most
- Concert Medical, LLC: 2 (https://510kreport.com/company/concert-medical)
- Teleflex Medical: 1 (https://510kreport.com/company/teleflex-medical)
- Opsens, Inc.: 1 (https://510kreport.com/company/opsens)
- Merit Medical Ireland, Ltd.: 1 (https://510kreport.com/company/merit-medical-ireland)
- Texasmedical Technologies, Inc.: 1 (https://510kreport.com/company/texasmedical-technologies)
- Abbott Medical: 1 (https://510kreport.com/company/abbott-medical)

## Its most-cited devices
- K151244: Pre-Formed Guidewire (2015), cited by 5
- K130798: Pre-Formed Guidewires (2013), cited by 2
- K160643: ENROUTE 0.014 Guidewire (2016), cited by 1
- K140485: Mandrel Guidewire (2014), cited by 1
- K140482: Mandrel Guidewire (2014), cited by 1
- K133155: Hydrophilic Coated Guidewire (2014), cited by 1

## Recent decisions
- K253746: Enroute 0.014'' Transcarotid Guidewire (Mar 19, 2026)
- K242824: PTFE Guidewire (Dec 6, 2024)
- K221575: Pre-Formed Blue (Oct 7, 2022)
- K211741: Pre-Formed Extra Support Guidewire (Nov 22, 2021)
- K160643: ENROUTE 0.014 Guidewire (Oct 18, 2016)
- K151244: Pre-Formed Guidewire (Jun 11, 2015)
- K140536: HI Torque Connect Guidewire, HI Torque Connect Flex Guidewire, HI Torque Connect 250T Guidewire (Dec 17, 2014)
- K142393: Predicate Iii Guidewire (Nov 25, 2014)

Source page: https://510kreport.com/company/lake-region-medical