Cleared Traditional

K894292 - BARD LIBERATOR DISPOSABLE INFUSION SYSTEM

K894292 is an FDA 510(k) clearance for BARD LIBERATOR DISPOSABLE INFUSION SYSTEM, manufactured by C.R. Bard, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K894292 · C.R. Bard, Inc. · General Hospital
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Nov 1989
Decision
132d
Days
Class 2
Risk

K894292 is an FDA 510(k) clearance for the BARD LIBERATOR DISPOSABLE INFUSION SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on November 2, 1989 after a review of 132 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K894292

510(k) Number K894292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1989
Decision Date November 02, 1989
Days to Decision 132 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
3d slower than avg
Panel avg: 129d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 582
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K894292.
IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICE
K895797 · Imed Corp. · Jan 1990
BECTON DICKINSON RATE INFUSER II SYSTEM
K896593 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
MODEL 600 SYRINGE PUMP
K891237 · 3M Company · Dec 1989
MODEL 285 INFUSION PUMP
K894321 · 3M Company · Oct 1989
MODEL 480 INFUSION PUMP
K894320 · 3M Company · Oct 1989
MODEL 280 INFUSION PUMP
K894360 · 3M Company · Oct 1989