Cleared Traditional

Pediatric Nasogastric Feeding Tubes - Single ENFit Port (K210598) - FDA 510(k) Clearance

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

K210598 · Cair Lgl · Gastroenterology & Urology device
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Nov 2021
Decision
246d
Days
Class 2
Risk

K210598 is an FDA 510(k) clearance for the Pediatric Nasogastric Feeding Tubes - Single ENFit Port. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Cair Lgl (Lissieu, FR). The FDA issued a Cleared decision on November 2, 2021 after a review of 246 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cair Lgl devices

Submission Details

510(k) Number K210598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2021
Decision Date November 02, 2021
Days to Decision 246 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
116d slower than avg
Panel avg: 130d · This submission: 246d
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

Vesco Medical
Glenn Brunner

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 K210598.
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
K213174 · Cardinalhealth · May 2022
Entuit PEG, Entuit PEGJ
K213356 · Wilson-Cook Medical, Inc. · Jan 2022
Enteral Feeding Set
K210854 · Kb Medical (Group), Inc. · Nov 2021
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