Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lake Region Mfg., Inc. — Predicate Candidate Screening
42 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
172 days90th percentile
42clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K092965 | TRAILRUNNER GUIDEWIRES | Lake Region Mfg., Inc. | 2010-02-26 | 154 | 0 |
| K082922 | FREEWAY AND RAILRUNNER GUIDEWIRES | Lake Region Mfg., Inc. | 2008-12-09 | 69 | 0 |
| K081708 | TAXI ENDOSCOPIC GUIDEWIRE | Lake Region Mfg., Inc. | 2008-08-26 | 70 | 0 |
| K080144 | MANDREL GUIDEWIRES OR M-WIRES | Lake Region Mfg., Inc. | 2008-02-26 | 35 | 0 |
| K073655 | PEGASUS STEERABLE (PTCA) GUIDEWIRE | Lake Region Mfg., Inc. | 2008-01-28 | 33 | 0 |
| K060454 | TITAN GUIDEWIRE | Lake Region Mfg., Inc. | 2006-03-24 | 30 | 0 |
| K052347 | TITAN STEERABLE (PTCA) GUIDEWIRE | Lake Region Mfg., Inc. | 2006-02-17 | 172 | 0 |
| K042338 | CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE | Lake Region Mfg., Inc. | 2004-09-16 | 17 | 0 |
| K041624 | PTCA STEERABLE HYDROPHILIC GUIDEWIRE | Lake Region Mfg., Inc. | 2004-07-16 | 30 | 0 |
| K040825 | LAKE REGION HYDROPHILIC GUIDEWIRE | Lake Region Mfg., Inc. | 2004-05-17 | 48 | 0 |
| K033758 | HYDROPHILIC GUIDEWIRE | Lake Region Mfg., Inc. | 2003-12-19 | 17 | 0 |
| K022813 | STEERABLE GUIDEWIRE | Lake Region Mfg., Inc. | 2003-02-14 | 172 | 0 |
| K011968 | STREERABLE PTCA GUIDEWIRE | Lake Region Mfg., Inc. | 2001-07-25 | 30 | 2 |
| K011084 | MANDREL GUIDEWIRE ASSEMBLY | Lake Region Mfg., Inc. | 2001-05-10 | 30 | 0 |
| K003483 | MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE) | Lake Region Mfg., Inc. | 2000-12-06 | 27 | 0 |
| K000011 | MODIFIED HYDROPHILIC COATED GUIDEWIRE | Lake Region Mfg., Inc. | 2000-03-01 | 58 | 0 |
| K971322 | CORE AND COIL ASSEMBLY GUIDEWIRE | Lake Region Mfg., Inc. | 1998-07-22 | 468 | 0 |
| K981326 | LAKE REGION MANUFACTURING GUIDEWIRES | Lake Region Mfg., Inc. | 1998-07-10 | 88 | 0 |
| K981667 | HYDROPHILIC COATED GUIDEWIRE | Lake Region Mfg., Inc. | 1998-06-05 | 25 | 0 |
| K970376 | PTCA GUIDEWIRE | Lake Region Mfg., Inc. | 1997-06-06 | 123 | 0 |
| K970994 | CORE AND COIL ASSEMBLY GUIDEWIRE | Lake Region Mfg., Inc. | 1997-03-25 | 6 | 0 |
| K960718 | LRM | Lake Region Mfg., Inc. | 1996-05-21 | 90 | 0 |
| K960866 | LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KI | Lake Region Mfg., Inc. | 1996-04-05 | 32 | 0 |
| K935198 | GASTROENTEROLOGY AND UROLOGY GUIDEWIRE MODIFICATIONS | Lake Region Mfg., Inc. | 1994-09-28 | 336 | 0 |
| K941229 | ONTRAC STEERABLE GUIDEWIRE | Lake Region Mfg., Inc. | 1994-05-12 | 58 | 0 |
| K935170 | CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS | Lake Region Mfg., Inc. | 1994-03-31 | 155 | 0 |
| K921200 | GUIDEWIRE | Lake Region Mfg., Inc. | 1992-09-04 | 176 | 0 |
| K914138 | ONTRAC | Lake Region Mfg., Inc. | 1991-12-13 | 88 | 0 |
| K913517 | ISOLATE INFUSION CATHETR SYSTEM | Lake Region Mfg., Inc. | 1991-11-05 | 90 | 0 |
| K912877 | PROFUSE INFUSION SYSTEM | Lake Region Mfg., Inc. | 1991-09-23 | 84 | 0 |
| K912878 | OPEN ENDED GUIDEWIRE | Lake Region Mfg., Inc. | 1991-09-11 | 72 | 0 |
| K905639 | TORQUE HANDLE DEVICE FOR GUIDEWIRE | Lake Region Mfg., Inc. | 1991-02-20 | 65 | 0 |
| K905581 | SILICONE COATED GUIDEWIRES | Lake Region Mfg., Inc. | 1991-02-19 | 69 | 0 |
| K901224 | INSITE STEERABLE GUIDEWIRE | Lake Region Mfg., Inc. | 1990-06-11 | 89 | 0 |
| K871882 | LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW) | Lake Region Mfg., Inc. | 1987-09-15 | 127 | 0 |
| K864058 | AMPLATZ MOVEABLE CORE GUIDEWIRE | Lake Region Mfg., Inc. | 1987-02-19 | 122 | 0 |
| K861469 | DUTHOY STONE BASKET | Lake Region Mfg., Inc. | 1986-05-15 | 23 | 0 |
| K861365 | FASICULATED NAIL | Lake Region Mfg., Inc. | 1986-05-06 | 25 | 0 |
| K850828 | WIRE, GUIDE - MODIFICATION | Lake Region Mfg., Inc. | 1985-06-26 | 121 | 0 |
| K850829 | WIRE, GUIDE, CATHETER | Lake Region Mfg., Inc. | 1985-06-26 | 121 | 0 |
| K850827 | GUIDE, WIRE, ANGIOGRAPHIC | Lake Region Mfg., Inc. | 1985-06-26 | 121 | 0 |
| K770977 | CARDIOVASCULAR SPRING GUIDES | Lake Region Mfg., Inc. | 1977-06-14 | 14 | 1 |
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