Cleared Special

K030888 - EVA EMPTY SOLUTION CONTAINER

K030888 is an FDA 510(k) clearance for EVA EMPTY SOLUTION CONTAINER, manufactured by Metrix Co.. The device is a Class 2 General Hospital device with product code KPE cleared through the Special 510(k) pathway after a 12-day FDA review.

K030888 · Metrix Co. · General Hospital
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Apr 2003
Decision
12d
Days
Class 2
Risk

K030888 is an FDA 510(k) clearance for the EVA EMPTY SOLUTION CONTAINER. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Metrix Co. (Dubuque, US). The FDA issued a Cleared decision on April 2, 2003 after a review of 12 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5025 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Metrix Co. devices

FDA 510(k) Submission Details - K030888

510(k) Number K030888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2003
Decision Date April 02, 2003
Days to Decision 12 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 129d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

KPE Device Classification - Class 2, Special Controls

Product Code KPE Container, I.v.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KPE Container, I.v.

All 60
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K030888.
DUAL CHAMBER TPN CONTAINER
K073538 · B.Braun Medical, Inc. · Mar 2008
KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER
K061197 · Kawasumi Laboratories, Inc. · Jun 2006
EVA TPN CONTAINER
K041415 · B.Braun Medical, Inc. · Aug 2004
ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML
K020485 · Baxter Healthcare Corp · Mar 2002
TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET
K001461 · Biometrix , Ltd. · Sep 2000
EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML
K001287 · Sorenson Medical, Inc. · Jun 2000