Cleared Traditional

K222773 - Feeding Tube

K222773 is an FDA 510(k) clearance for Feeding Tube, manufactured by Anhui Tiankang Medical Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code PIF cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K222773 · Anhui Tiankang Medical Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K222773

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.

PIF Device Classification - Class 2, Special Controls

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 37
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