Cleared Traditional

K901225 - LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR)

K901225 is an FDA 510(k) clearance for LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR), manufactured by Abbott Laboratories. The device is a Class 1 General Hospital device with product code KZD cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K901225 · Abbott Laboratories · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
162d
Days
Class 1
Risk

K901225 is an FDA 510(k) clearance for the LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR). Classified as Infusor, Pressure, For I.v. Bags (product code KZD), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 23, 1990 after a review of 162 days - an extended review 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: 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K901225

510(k) Number K901225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1990
Decision Date August 23, 1990
Days to Decision 162 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 129d · This submission: 162d
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 9
Devices cleared under the same product code (KZD) and FDA review panel - the closest regulatory comparables to K901225.
OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP
K953290 · Olympus America, Inc. · Oct 1995
DATA TRAC ANESTHESIOLOGY RECORDER
K851904 · Datascope Corp. · May 1985
NORFOLK/NORWICH PRESSURE INFUSION BOX
K810954 · Medical Innovations Corp. · Apr 1981
MX820-5 PRESSURE INFUSOR 500CC MX820-10
K800560 · Medex, Inc. · Apr 1980
VOLUME CONTROL DEVICE VCD-150
K780465 · Sorensen Research · Jun 1978
INFUSION ACCELERATOR
K771458 · Terumo America, Inc. · Aug 1977