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Enteral Bag/Set (K890151)

by Ashley Health Care, Inc.

510(k) K890151

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 NumberK890151 Date23 May 1989ClearedStatusActive

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  • Withdrawn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)

Full name
Enteral Bag/Set
510(k) Number
FDA Product Code
KNT
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

The Enteral Bag/Set (K890151) is a medical device classified under 21 CFR 876.5980, designed for the administration of enteral nutrition. It consists of a bag and associated tubing to deliver liquid nutritional formulas directly into the gastrointestinal tract, supporting patients requiring alternative feeding methods.

This device is intended for single-use and is supplied sterile, adhering to FDA 510(k) clearance (K890151) under the Gastroenterology and Urology advisory committees. It is regulated under the Traditional 510(k) review pathway and falls under product code KNT. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality.

Other devices from Ashley Health Care, Inc.

Questions

AI-generated answers, 19 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 is the Enteral Bag/Set designed to do, and who would use it?

    The Enteral Bag/Set is specifically designed to deliver liquid nutritional formulas directly into the gastrointestinal tract, serving patients who require alternative feeding methods due to swallowing difficulties or other conditions. Clinicians use it for patients needing enteral nutrition, such as those in critical care, rehabilitation, or long-term care settings.

  • Is this device meant for repeated use, or is it single-use only?

    This device is explicitly intended for single-use only. It is supplied sterile to ensure patient safety, and reusing it could compromise sterility and functionality, potentially leading to contamination or device failure.

  • How should I store the Enteral Bag/Set to keep it effective?

    Storage must follow the manufacturer’s guidelines to preserve sterility and functionality. Since it is sterile upon supply, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use. Avoid exposing it to moisture or contaminants that could compromise its integrity.

  • What regulatory pathway was followed for FDA clearance, and what does that mean for me?

    The Enteral Bag/Set received FDA clearance through the Traditional 510(k) review pathway, classified under product code KNT and reviewed by the Gastroenterology and Urology advisory committees. This means the device was deemed *substantially equivalent* to a legally marketed predicate, ensuring it meets established safety and performance standards for enteral nutrition delivery.