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AMSure Enteral Feeding Pump

by Amsino International, Inc.

510(k) K220230

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK220230 Date10 Nov 2022ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LZH
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An enteral feeding pump is a device designed to deliver nutritional formulas or medications through a feeding tube into the gastrointestinal tract. The AMSure Enteral Feeding Pump is a Class II medical device intended for use in general hospital settings to administer enteral nutrition.

The device is supplied as a reusable pump unit and is used with single-use feeding sets, syringes, and irrigation kits. It operates under FDA 510(k) clearance (K220230) and is classified under product code LZH with regulation number 880.5725. Storage and handling should follow manufacturer guidelines as outlined in the user manual.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical purpose does the AMSure Enteral Feeding Pump serve?

    The pump is designed to deliver nutritional formulas or medications through a feeding tube into a patient’s gastrointestinal tract, providing enteral nutrition in general hospital settings where oral intake is insufficient or contraindicated.

  • How is the AMSure system supplied and which parts are single‑use?

    The system is supplied as a reusable pump unit that is paired with single‑use feeding sets, syringes, and irrigation kits. The disposable components ensure sterility for each patient while the pump itself can be cleaned and reused according to the manufacturer’s instructions.

  • Can the AMSure pump be reused, and what cleaning procedures are required?

    Yes, the pump is a reusable unit. After each patient use it must be cleaned and disinfected following the manufacturer’s user manual, which outlines recommended cleaning agents, disassembly steps, and storage conditions to maintain performance and safety.

  • What regulatory pathway did the AMSure Enteral Feeding Pump follow?

    The device received FDA 510(k) clearance (K220230) as a Class II medical device, indicating it is substantially equivalent to a legally marketed predicate device and meets the applicable regulatory requirements for hospital‑based enteral feeding pumps.

  • How should the AMSure pump be stored when not in use?

    Storage and handling should follow the manufacturer’s guidelines detailed in the user manual, which typically include keeping the pump in a clean, dry environment, protected from extreme temperatures, and ensuring that any attached accessories are removed to prevent contamination.