Cleared Traditional

K852162 - MNI 400 INJECTION CAPS

K852162 is an FDA 510(k) clearance for MNI 400 INJECTION CAPS, manufactured by Med-West, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LFJ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K852162 · Med-West, Inc. · Gastroenterology & Urology device
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Jun 1985
Decision
23d
Days
Class 2
Risk

K852162 is an FDA 510(k) clearance for the MNI 400 INJECTION CAPS. Classified as Catheter, Subclavian (product code LFJ), Class II - Special Controls.

Submitted by Med-West, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on June 12, 1985 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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 Med-West, Inc. devices

FDA 510(k) Submission Details - K852162

510(k) Number K852162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1985
Decision Date June 12, 1985
Days to Decision 23 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 131d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFJ Device Classification - Class 2, Special Controls

Product Code LFJ Catheter, Subclavian
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 - LFJ Catheter, Subclavian

All 64
Devices cleared under the same product code (LFJ) and FDA review panel - the closest regulatory comparables to K852162.
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