Cleared Traditional

K891077 - MEDIVERSE PARENTERAL NUTRITION BAG

K891077 is the FDA 510(k) clearance for MEDIVERSE PARENTERAL NUTRITION BAG by Mediflex Intl.. It is a Class 2 General Hospital device (product code KPE) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K891077 · Mediflex Intl. · General Hospital
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May 1989
Decision
84d
Days
Class 2
Risk

K891077 is an FDA 510(k) clearance for the MEDIVERSE PARENTERAL NUTRITION BAG. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Mediflex Intl. (Fairfield, US). The FDA issued a Cleared decision on May 24, 1989 after a review of 84 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mediflex Intl. devices

Submission Details

510(k) Number K891077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1989
Decision Date May 24, 1989
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 38
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K891077.
UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET
K932477 · Baxter Healthcare Corp · Jun 1994
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
NUTRIMIX EMPTY CONTAINER
K860042 · Abbott Laboratories · Apr 1986
VIAL DECANTER
K852893 · Advance Medical Designs, Inc. · Sep 1985