Cleared Traditional

K040825 - LAKE REGION HYDROPHILIC GUIDEWIRE

K040825 is an FDA 510(k) clearance for LAKE REGION HYDROPHILIC GUIDEWIRE, manufactured by Lake Region Mfg., Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K040825 · Lake Region Mfg., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
48d
Days
Class 2
Risk

K040825 is an FDA 510(k) clearance for the LAKE REGION HYDROPHILIC GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Lake Region Mfg., Inc. (Chaska, US). The FDA issued a Cleared decision on May 17, 2004 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lake Region Mfg., Inc. devices

FDA 510(k) Submission Details - K040825

510(k) Number K040825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2004
Decision Date May 17, 2004
Days to Decision 48 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQX Wire, Guide, Catheter

All 541
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K040825.
CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
K042338 · Lake Region Mfg., Inc. · Sep 2004
ASAHI PTCA GUIDE WIRE CONFIANZA PRO
K041531 · Asahi Intecc Co., Ltd. · Aug 2004
PTCA STEERABLE HYDROPHILIC GUIDEWIRE
K041624 · Lake Region Mfg., Inc. · Jul 2004
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
K040867 · Boston Scientific Corp · Apr 2004
MODIFICATION TO NITREX NITINOL GUIDEWIRE
K040345 · Ev3, Inc. · Mar 2004
ARROW ECHOGENIC INTRODUCER NEEDLE
K040100 · Arrow Intl., Inc. · Mar 2004