Cleared Traditional

Mobility+ Enteral Feeding System (K222678) - FDA 510(k) Clearance

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

K222678 · Rockfield Medical · Gastroenterology & Urology device
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Oct 2022
Decision
51d
Days
Class 2
Risk

K222678 is an FDA 510(k) clearance for the Mobility+ Enteral Feeding System. Classified as Gastrointestinal Tubes With Enteral Specific Connectors (product code PIF), Class II - Special Controls.

Submitted by Rockfield Medical (Galway, IE). The FDA issued a Cleared decision on October 27, 2022 after a review of 51 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 Rockfield Medical devices

Submission Details

510(k) Number K222678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2022
Decision Date October 27, 2022
Days to Decision 51 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
79d faster than avg
Panel avg: 130d · This submission: 51d
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 K222678.
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
Feeding Tube
K222773 · Anhui Tiankang Medical Technology Co., Ltd. · Aug 2023
EnteraLoc Flow
K223683 · Vonco Products · Jul 2023
Nasogastric Feeding Tubes - ENFit Port - PVC
K213258 · Cair Lgl · Jun 2022
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