Cleared Traditional

K942933 - PRESSURE INFUSION CUFF

K942933 is the FDA 510(k) clearance for PRESSURE INFUSION CUFF by Circulatory Technology, Inc.. It is a Class 1 General Hospital device (product code KZD) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K942933 · Circulatory Technology, Inc. · General Hospital
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Aug 1994
Decision
64d
Days
Class 1
Risk

K942933 is an FDA 510(k) clearance for the PRESSURE INFUSION CUFF. Classified as Infusor, Pressure, For I.v. Bags (product code KZD), Class I - General Controls.

Submitted by Circulatory Technology, Inc. (Oyster Bay, US). The FDA issued a Cleared decision on August 25, 1994 after a review of 64 days - a notably fast clearance cycle.

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: 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 Circulatory Technology, Inc. devices

Submission Details

510(k) Number K942933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1994
Decision Date August 25, 1994
Days to Decision 64 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
65d faster than avg
Panel avg: 129d · This submission: 64d
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

Devices cleared under the same product code (KZD) and FDA review panel - the closest regulatory comparables to K942933.
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
BLOOD-SOLUTION ADMINISTRATION SET, SURG.
K760483 · Travenol Laboratories, S.A. · Sep 1976
SOLUTION ADMINISTRATION SET (#2C0631)
K760505 · Travenol Laboratories, S.A. · Sep 1976