Cleared Traditional

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

K890268 is an FDA 510(k) clearance for PRESSURE INFUSOR FOR I.V. BAGS/AUTOINFL..., manufactured by Biomedical Dynamics, Inc.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K890268

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.

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 57
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K890268.
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
NUTRIMIX EMPTY CONTAINER
K860042 · Abbott Laboratories · Apr 1986