Cleared Traditional

K890268 - PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFL...

K890268 is the FDA 510(k) clearance for PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFL... by Biomedical Dynamics, Inc.. It is a Class 2 General Hospital device (product code KPE) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K890268 · Biomedical Dynamics, Inc. · General Hospital
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May 1989
Decision
107d
Days
Class 2
Risk

K890268 is an FDA 510(k) clearance for the PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFLATION. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Biomedical Dynamics, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 5, 1989 after a review of 107 days - within the typical 510(k) review window.

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 Biomedical Dynamics, Inc. devices

Submission Details

510(k) Number K890268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1989
Decision Date May 05, 1989
Days to Decision 107 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
22d faster than avg
Panel avg: 129d · This submission: 107d
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 35
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K890268.
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
NUTRIMIX EMPTY CONTAINER
K844077 · Abbott Laboratories · Feb 1985