Cleared Traditional

K202357 - Nutricare Clear-ISOSAF Nasogastric Feed...

K202357 is the FDA 510(k) clearance for Nutricare Clear-ISOSAF Nasogastric Feed... by Three Circles Consulting Limited. It is a Class 2 Gastroenterology & Urology device (product code PIF) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K202357 · Three Circles Consulting Limited · Gastroenterology & Urology device
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Oct 2020
Decision
43d
Days
Class 2
Risk

K202357 is an FDA 510(k) clearance for the Nutricare Clear-ISOSAF Nasogastric Feeding Tube. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Three Circles Consulting Limited (Keele, GB). The FDA issued a Cleared decision on October 1, 2020 after a review of 43 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 Three Circles Consulting Limited devices

Submission Details

510(k) Number K202357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2020
Decision Date October 01, 2020
Days to Decision 43 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 130d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PIF Gastrointestinal Tubes With Enteral Specific Connectors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
Definition To Facilitate Enteral Specific Connections.
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

Gbuk Group Limited
Matthew Theobald

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 - PIF Gastrointestinal Tubes With Enteral Specific Connectors

All 36
Devices cleared under the same product code (PIF) and FDA review panel - the closest regulatory comparables to K202357.
Enteral Extension Sets
K203633 · GBUK Group, Ltd. · Aug 2021
EnteraLoc Flow
K210971 · Vonco Products · Aug 2021
Gabriel 3 Way EnFit Valve
K201741 · Syncro Medical Innovations, Inc. · Nov 2020
Vesco Medical Extension Feeding Set
K192991 · Vesco Medical, LLC · Aug 2020
BD Univia RightFit Enteral Extension Sets and Transitional Adapters
K200082 · Mps Medical, Inc. · Jul 2020
Medline Quick Switch Valve with ENFit Connector
K191759 · Medline Industries, Inc. · Dec 2019