KPE · Class II · 21 CFR 880.5025

FDA Product Code KPE: Container, I.v.

Under FDA product code KPE, intravenous fluid containers are cleared for the storage and delivery of sterile IV solutions.

These flexible plastic bags or rigid bottles contain sterile isotonic, hypertonic, or hypotonic solutions — including saline, dextrose, and lactated Ringer's — for intravenous fluid and electrolyte replacement. They are a fundamental component of fluid therapy across all clinical settings.

KPE devices are Class II medical devices, regulated under 21 CFR 880.5025 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Baxter Healthcare Corp, Abbott Laboratories and Baxa Corp., Sub. of Cook Group, Inc..

117

Total

117

Cleared

108d

Avg days

1976

Since

117 devices

25–48 of 117

Cleared Nov 24, 2003

GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML

Laboratorios Grifols, S.A.

General Hospital · 203d

Cleared Apr 02, 2003

EVA EMPTY SOLUTION CONTAINER

General Hospital · 12d

Cleared Mar 12, 2002

ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML

Baxter Healthcare Corp

General Hospital · 27d

Cleared Sep 11, 2000

TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET

Biometrix , Ltd.

General Hospital · 124d

Cleared Jun 09, 2000

EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML

Sorenson Medical, Inc.

General Hospital · 46d

Cleared Nov 03, 1998

ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712

Baxter Healthcare Corp

General Hospital · 43d

Cleared Jul 27, 1998

MPS RESERVOIR BAG

Medical Product Specialists

General Hospital · 47d

Cleared Feb 24, 1998

General Hospital · 110d

Cleared Nov 24, 1997

CHARTERMED TPN-EVA BAGS

Chartermed, Inc.

General Hospital · 97d

Cleared Nov 05, 1997

VITALMIX PLUS EMPTY I.V. CONTAINER

Pacific Device, Inc.

General Hospital · 127d

Cleared Mar 31, 1997

INTRAVIA CONTAINER, EMPTY

Baxter Healthcare Corp

General Hospital · 118d

Cleared Apr 30, 1996

SECURE EVA DUAL CHAMBER MIXING BAG

Secure Medical Products, Inc.

General Hospital · 78d

Cleared May 12, 1995

ALL-IN-ONE TWO CHAMBER CONTAINER

Baxter Healthcare Corp

General Hospital · 200d

Cleared Jul 22, 1994

EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET

General Hospital · 106d

Cleared Jun 10, 1994

UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET

Baxter Healthcare Corp

General Hospital · 382d

Cleared May 23, 1994

DISPOSABLE BAG DECANTER

General Hospital · 270d

Cleared Mar 28, 1994

SOLUTION TRANSFER CONTAINER W/ATTACHED LEG SET (EMPTY)

General Hospital · 66d

Cleared Nov 16, 1993

General Hospital · 167d

Cleared Nov 10, 1993

EVA EMPTY MIXING CONTAINER

Douglas Medical Products Corp.

General Hospital · 161d

Cleared Nov 10, 1993

EMPTY MIXING CONTAINER

Douglas Medical Products Corp.

General Hospital · 161d

Cleared Sep 03, 1993

DUAL CHAMBER MIXING BAG

Secure Medical, Inc.

General Hospital · 273d

Cleared Jul 28, 1993

EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG

Healthtek, Inc.

General Hospital · 379d

Cleared Mar 26, 1993

EMPTY VIAFLEX PLASTIC CONTAINER

Baxter Healthcare Corp

General Hospital · 318d

Cleared Nov 29, 1991

Healthtek, Inc.

General Hospital · 107d