Cleared Traditional

Fidmi Low Profile Enteral Feeding Device (K191844) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191844 · Fidmi Medical, Ltd. · Gastroenterology & Urology device
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Sep 2019
Decision
83d
Days
Class 2
Risk

K191844 is an FDA 510(k) clearance for the Fidmi Low Profile Enteral Feeding Device. Classified as Tube, Gastro-enterostomy (product code KGC), Class II - Special Controls.

Submitted by Fidmi Medical, Ltd. (Caesarea Business Park, Caesarea, IL). The FDA issued a Cleared decision on September 30, 2019 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - 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 Fidmi Medical, Ltd. devices

Submission Details

510(k) Number K191844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2019
Decision Date September 30, 2019
Days to Decision 83 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
47d faster than avg
Panel avg: 130d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KGC Tube, Gastro-enterostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 Consultant

Hogan Lovells US LLP
Janice M. Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KGC Tube, Gastro-enterostomy

All 25
Devices cleared under the same product code (KGC) and FDA review panel - the closest regulatory comparables to K191844.
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