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Life Care 1000ML.EMP. Cont. W/at. Y-Tran

by Abbott Laboratories

510(k) K791774

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 NumberK791774 Date26 Oct 1979ClearedStatusActive

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  • Withdrawn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
KPE
Device Class
Class II
Regulation
21 CFR Part 880.5025
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Life Care 1000ml Emp. Cont. W/At. Y-tran is an intravenous container designed for medical use. It is a sterile container with a capacity of 1000ml and includes a Y-transfusion port for administration of fluids.

This device is supplied as a single-use item and is intended for use in general hospital settings. It has FDA 510(k) clearance with the product code KPE and was classified as substantially equivalent in 1979. The device is manufactured by Abbott Laboratories and is regulated under number 880.5025.

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Questions

AI-generated answers, 27 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 Life Care 1000ml Emp. Cont. W/At. Y-tran used for?

    This is a sterile intravenous container designed for medical use with a 1000ml capacity and includes a Y-transfusion port for administration of fluids in general hospital settings.

  • Is the Life Care 1000ml container single-use or reusable?

    The device is supplied as a single-use item and is intended for one-time use only in medical procedures.

  • What are the regulatory details for this IV container?

    The device has FDA 510(k) clearance with product code KPE and was classified as substantially equivalent in 1979. It is regulated under number 880.5025.

  • Who manufactures the Life Care 1000ml IV container?

    The device is manufactured by Abbott Laboratories, located at One Abbott Park Rd., Abbott Park, IL 60064.