Cleared Traditional

K895922 - METRICARE EMPTY CONTAINER SYSTEMS

K895922 is an FDA 510(k) clearance for METRICARE EMPTY CONTAINER SYSTEMS, manufactured by Metrix Co.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K895922 · Metrix Co. · General Hospital
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Aug 1990
Decision
315d
Days
Class 2
Risk

K895922 is an FDA 510(k) clearance for the METRICARE EMPTY CONTAINER SYSTEMS. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Metrix Co. (Dubuque, US). The FDA issued a Cleared decision on August 22, 1990 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Metrix Co. devices

FDA 510(k) Submission Details - K895922

510(k) Number K895922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1989
Decision Date August 22, 1990
Days to Decision 315 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 129d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - LHI Set, I.v. Fluid Transfer

All 153
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K895922.
ACACIAS PHARM/PUMP
K912771 · Acacia, Inc. · Feb 1992
NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION
K910213 · Abbott Laboratories · Apr 1991
RECONSTITUTION DEVICE
K910793 · Baxter Healthcare Corp · Mar 1991
LUER LOCK TRANSFER PIN
K901063 · Acacia, Inc. · Jul 1990
NUTRIMIX MACRO TPN COMPOUNDER
K901404 · Abbott Laboratories · Jun 1990
PHARMULATOR
K896990 · Acacia, Inc. · Mar 1990