Cleared Traditional

K831347 - MICROCAPILLARY INFUSION SYSTEM

K831347 is the FDA 510(k) clearance for MICROCAPILLARY INFUSION SYSTEM by J.S. Biomedicals, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FFX) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K831347 · J.S. Biomedicals, Inc. · Gastroenterology & Urology device
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Jun 1983
Decision
38d
Days
Class 2
Risk

K831347 is an FDA 510(k) clearance for the MICROCAPILLARY INFUSION SYSTEM. Classified as System, Gastrointestinal Motility (electrical) (product code FFX), Class II - Special Controls.

Submitted by J.S. Biomedicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1725 - 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 J.S. Biomedicals, Inc. devices

Submission Details

510(k) Number K831347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1983
Decision Date June 02, 1983
Days to Decision 38 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
92d faster than avg
Panel avg: 130d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FFX System, Gastrointestinal Motility (electrical)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1725
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 - FFX System, Gastrointestinal Motility (electrical)

All 19
Devices cleared under the same product code (FFX) and FDA review panel - the closest regulatory comparables to K831347.
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GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER
K874690 · Mentor Corp. · Feb 1988
SYN-02 PN AMPLIFIER
K830421 · Biosearch Medical Products, Inc. · Apr 1983
ESOPHAGEAL MOTILITY APPARATUS
K812103 · Honeywell, Inc. · Aug 1981
ESOPHAGEAL MOTILITY SYSTEM - MODEL 3330
K780812 · Honeywell, Inc. · Jun 1978