Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Lake Region Medical · Predicate Candidate Screening

16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

88 daysmedian FDA review time
225 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253746Enroute 0.014'' Transcarotid GuidewireLake Region Medical2026-03-191140
K242824PTFE GuidewireLake Region Medical2024-12-06790
K221575Pre-Formed BlueLake Region Medical2022-10-071280
K211741Pre-Formed Extra Support GuidewireLake Region Medical2021-11-221680
K160643ENROUTE 0.014 GuidewireLake Region Medical2016-10-182250
K151244Pre-Formed GuidewireLake Region Medical2015-06-11310
K140536HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRLake Region Medical2014-12-172880
K142393PREDICATE III GUIDEWIRELake Region Medical2014-11-25900
K142397Predicate III GuidewireLake Region Medical2014-09-19230
K140482MANDREL GUIDEWIRELake Region Medical2014-04-08410
K133155HYDROPHILIC COATED GUIDEWIRELake Region Medical2014-04-071720
K140485MANDREL GUIDEWIRELake Region Medical2014-03-27290
K124052OSTAVI HYDROPHILIC GUIDEWIRELake Region Medical2013-02-26570
K112381HI TORQUE CONNECT GUIDEWIRELake Region Medical2011-11-03780
K111288ANCHORWIRE GUIDEWIRELake Region Medical2011-08-02880
K080508MANDREL GUIDEWIRES OR M-WIRELake Region Medical2008-03-21250

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda