Cleared Traditional

Feeding Tube (K222773) - FDA 510(k) Clearance

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

K222773 · Anhui Tiankang Medical Technology Co., Ltd. · Gastroenterology & Urology device
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Aug 2023
Decision
337d
Days
Class 2
Risk

K222773 is an FDA 510(k) clearance for the Feeding Tube. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Anhui Tiankang Medical Technology Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on August 17, 2023 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Anhui Tiankang Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K222773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2022
Decision Date August 17, 2023
Days to Decision 337 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 130d · This submission: 337d
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 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 K222773.
Mobility+ Enteral Feeding System OTC
K233034 · Rockfield Medical · Apr 2024
ENFit to ENFit Extension Sets
K230326 · Vesco Medical · Nov 2023
Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection
K232046 · Xeridiem Medical Devices, A Spectrum Plastics Group Company · Oct 2023
EnteraLoc Flow
K223683 · Vonco Products · Jul 2023
Mobility+ Enteral Feeding System
K222678 · Rockfield Medical · Oct 2022
Nasogastric Feeding Tubes - ENFit Port - PVC
K213258 · Cair Lgl · Jun 2022