Cleared Traditional

K951988 - PRESSURIZER

K951988 is an FDA 510(k) clearance for PRESSURIZER, manufactured by Promedic, Inc.. The device is a Class 1 General Hospital device with product code KZD cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K951988 · Promedic, Inc. · General Hospital
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Jun 1995
Decision
48d
Days
Class 1
Risk

K951988 is an FDA 510(k) clearance for the PRESSURIZER. Classified as Infusor, Pressure, For I.v. Bags (product code KZD), Class I - General Controls.

Submitted by Promedic, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 14, 1995 after a review of 48 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.

FDA 510(k) Submission Details - K951988

510(k) Number K951988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1995
Decision Date June 14, 1995
Days to Decision 48 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 129d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

KZD Device Classification - Class 1, General Controls

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 16
Devices cleared under the same product code (KZD) and FDA review panel - the closest regulatory comparables to K951988.
INFUSION DYNAMICS POWER INFUSER
K974074 · Infusion Dynamics, Inc. · Feb 1998
MSI PRESSURE INFUSOR
K973843 · Smith Assoc. · Oct 1997
OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP
K953290 · Olympus America, Inc. · Oct 1995
PRESSURE INFUSION CUFF
K942933 · Circulatory Technology, Inc. · Aug 1994
KAWASUMI LABORATORIES K-CUFF
K930012 · Kawasumi Laboratories Co., Ltd. · Dec 1993
LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR)
K901225 · Abbott Laboratories · Aug 1990