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Metricare Enteral Feeding System

by Metrix Co.

510(k) K895923

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 NumberK895923 Date19 Jul 1990ClearedStatusActive

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  • Withdrawn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
FPD
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 Metricare Enteral Feeding System is a Tube, Feeding (OpenFDA classification) designed for the administration of enteral nutrition. It provides a controlled pathway for delivering liquid nutrients directly into the gastrointestinal tract, supporting patients requiring alternative feeding methods due to swallowing difficulties or digestive disorders.

This system is intended for single-use in clinical settings such as hospitals, nursing homes, or home healthcare environments. Supplied sterile and packaged individually, it adheres to FDA 510(k) clearance (K895923) under regulation 876.5980, classified as a Class II medical device. Multiple tube sizes and configurations are available, as referenced by the associated FEI numbers, ensuring compatibility with various patient needs and procedural requirements.

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