Cleared Traditional

K960866 - LRM PRODUCES GUIDEWIRES ON AN OEM BASIS...

K960866 is an FDA 510(k) clearance for LRM PRODUCES GUIDEWIRES ON AN OEM BASIS..., 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 32-day FDA review.

K960866 · Lake Region Mfg., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
32d
Days
Class 2
Risk

K960866 is an FDA 510(k) clearance for the LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND.... 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 April 5, 1996 after a review of 32 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 - K960866

510(k) Number K960866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1996
Decision Date April 05, 1996
Days to Decision 32 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
98d faster than avg
Panel avg: 130d · This submission: 32d
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 K960866.
HYDROPHILIC COATED GUIDEWIRE
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K972977 · Cook Urological, Inc. · Oct 1997
MANAN MANTA CATHETER FIXATION DISK
K954132 · Manan Medical Products, Inc. · Mar 1996
KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP
K951488 · The Kendal Co. · Apr 1995
PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID
K943835 · Orion Life Systems, Inc. · Jan 1995