Cleared Traditional

CONOD Enteral Feeding Sets (K181276) - FDA 510(k) Clearance

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

K181276 · Conod Medical Co., Limited · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
59d
Days
Class 2
Risk

K181276 is an FDA 510(k) clearance for the CONOD Enteral Feeding Sets. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Conod Medical Co., Limited (Changshu, CN). The FDA issued a Cleared decision on July 12, 2018 after a review of 59 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 Conod Medical Co., Limited devices

Submission Details

510(k) Number K181276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2018
Decision Date July 12, 2018
Days to Decision 59 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
71d faster than avg
Panel avg: 130d · This submission: 59d
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

Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
Mike Gu

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 K181276.
Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes
K181787 · Cedic S.R.L. · Apr 2019
ENConnect 40 mm Screw Cap to ENPlus Adapter
K190327 · Cedic S.R.L. · Apr 2019
Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit
K180708 · Xeridiem Medical Devices, A Spectrum Plastics Group Company · Oct 2018
Medline ENFit Syringe
K160642 · Medline Industries, Inc. · Nov 2016
EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector
K161003 · Boston Scientific Corporation · Jun 2016
Salem Sump Dual Lumen Stomach Tube with Multi-functional Port
K150711 · Covidien · Oct 2015