Cleared Traditional

K981667 - HYDROPHILIC COATED GUIDEWIRE

K981667 is an FDA 510(k) clearance for HYDROPHILIC COATED GUIDEWIRE, manufactured by Lake Region Mfg., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K981667 · Lake Region Mfg., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
25d
Days
Class 2
Risk

K981667 is an FDA 510(k) clearance for the HYDROPHILIC COATED GUIDEWIRE. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Lake Region Mfg., Inc. (Chaska, US). The FDA issued a Cleared decision on June 5, 1998 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology device 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 - K981667

510(k) Number K981667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1998
Decision Date June 05, 1998
Days to Decision 25 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 130d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

Product Code KNY Accessories, Catheter, G-u
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNY Accessories, Catheter, G-u

All 23
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K981667.
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K981229 · Medical Device Technologies, Inc. · Apr 1998
INSULATOR WIRE GUIDE
K972977 · Cook Urological, Inc. · Oct 1997
LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.
K960866 · Lake Region Mfg., Inc. · Apr 1996
MANAN MANTA CATHETER FIXATION DISK
K954132 · Manan Medical Products, Inc. · Mar 1996