Cleared Traditional

Vesco Q™ Enteral Feeding Pump (K232205) - FDA 510(k) Clearance

Also marketed or referenced as:
Vesco Q™ 500mL Bag Feed Set Vesco Q™ 1000mL Bag Feed Set Vesco Q™ 40mm Screw Cap Feed Set Vesco Q™ ENPlus Feed Set

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232205 · Vesco Medical, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
90d
Days
Class 2
Risk

K232205 is an FDA 510(k) clearance for the Vesco Q™ Enteral Feeding Pump. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Vesco Medical, LLC (Westerville, US). The FDA issued a Cleared decision on October 23, 2023 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Vesco Medical, LLC devices

Submission Details

510(k) Number K232205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2023
Decision Date October 23, 2023
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZH Pump, Infusion, Enteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 General Hospital devices follow this clearance model.

Regulatory Peers - LZH Pump, Infusion, Enteral

All 11
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K232205.
Luminoah FLOW™ Enteral Nutrition System
K253558 · Luminoah · Apr 2026
Kangaroo OMNI™ Enteral Feeding Pump (385400 )
K221603 · Cardinal Health, LLC · Dec 2022
AMSure Enteral Feeding Pump
K220230 · Amsino International, Inc. · Nov 2022
PUGGLE Enteral Feeding Pump and Feeding Set
K200051 · Amsino International, Inc. · Sep 2020
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
K153074 · Covidien · Jul 2016
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
K143263 · Covidien · May 2015