Cleared Traditional

K870052 - INFUMIX MIXING CONTAINER

K870052 is an FDA 510(k) clearance for INFUMIX MIXING CONTAINER, manufactured by Biodynamics Corp.. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K870052 · Biodynamics Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
51d
Days
Class 2
Risk

K870052 is an FDA 510(k) clearance for the INFUMIX MIXING CONTAINER. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Biodynamics Corp. (Houston, US). The FDA issued a Cleared decision on February 27, 1987 after a review of 51 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 Biodynamics Corp. devices

FDA 510(k) Submission Details - K870052

510(k) Number K870052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1987
Decision Date February 27, 1987
Days to Decision 51 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 129d · This submission: 51d
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 51
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K870052.
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
BAG DECANTER
K852777 · Advance Medical Designs, Inc. · Aug 1985