Cleared Traditional

K913751 - PRESSURE INFUSER

K913751 is the FDA 510(k) clearance for PRESSURE INFUSER by Biomedical Dynamics, Inc.. It is a Class 1 General Hospital device (product code KZD) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K913751 · Biomedical Dynamics, Inc. · General Hospital
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Jan 1992
Decision
141d
Days
Class 1
Risk

K913751 is an FDA 510(k) clearance for the PRESSURE INFUSER. Classified as Infusor, Pressure, For I.v. Bags (product code KZD), Class I - General Controls.

Submitted by Biomedical Dynamics, Inc. (Burnsville, US). The FDA issued a Cleared decision on January 9, 1992 after a review of 141 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5420 - 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 K913751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1991
Decision Date January 09, 1992
Days to Decision 141 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 129d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KZD Infusor, Pressure, For I.v. Bags
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KZD Infusor, Pressure, For I.v. Bags

All 7
Devices cleared under the same product code (KZD) and FDA review panel - the closest regulatory comparables to K913751.
OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP
K953290 · Olympus America, Inc. · Oct 1995
LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR)
K901225 · Abbott Laboratories · Aug 1990
DATA TRAC ANESTHESIOLOGY RECORDER
K851904 · Datascope Corp. · May 1985
MX820-5 PRESSURE INFUSOR 500CC MX820-10
K800560 · Medex, Inc. · Apr 1980
VOLUME CONTROL DEVICE VCD-150
K780465 · Sorensen Research · Jun 1978
BLOOD-SOLUTION ADMINISTRATION SET, SURG.
K760483 · Travenol Laboratories, S.A. · Sep 1976