Cleared Traditional

K895924 - METRICARE DRUG RESERVOIRS

K895924 is an FDA 510(k) clearance for METRICARE DRUG RESERVOIRS, manufactured by Metrix Co.. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K895924 · Metrix Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1990
Decision
288d
Days
Class 2
Risk

K895924 is an FDA 510(k) clearance for the METRICARE DRUG RESERVOIRS. 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 July 26, 1990 after a review of 288 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5025 - 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. Standard predicate reliance. 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 - K895924

510(k) Number K895924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1989
Decision Date July 26, 1990
Days to Decision 288 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
159d slower than avg
Panel avg: 129d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K895924.
EVA EMPTY MIXING CONTAINER
K932640 · Douglas Medical Products Corp. · Nov 1993
EMPTY MIXING CONTAINER
K932641 · Douglas Medical Products Corp. · Nov 1993
EMPTY VIAFLEX PLASTIC CONTAINER
K922214 · Baxter Healthcare Corp · Mar 1993
OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE
K883400 · Abbott Laboratories · Dec 1989
CHURCHILL PARENTERAL NUTRITION BAG - EVA
K870395 · Churchill Corp. · Oct 1987
INFUMIX MIXING CONTAINER
K870052 · Biodynamics Corp. · Feb 1987