Cleared Traditional

K904403 - BARD AMBULATORY PCA DRUG DELIVERY SYSTEM

K904403 is an FDA 510(k) clearance for BARD AMBULATORY PCA DRUG DELIVERY 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 94-day FDA review.

K904403 · C.R. Bard, Inc. · General Hospital
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Dec 1990
Decision
94d
Days
Class 2
Risk

K904403 is an FDA 510(k) clearance for the BARD AMBULATORY PCA DRUG DELIVERY SYSTEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (North Reading, US). The FDA issued a Cleared decision on December 28, 1990 after a review of 94 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.

FDA 510(k) Submission Details - K904403

510(k) Number K904403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1990
Decision Date December 28, 1990
Days to Decision 94 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
35d faster than avg
Panel avg: 129d · This submission: 94d
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 846
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K904403.
MICREL LTD PORTABLE INFUSION MICROPUMP
K903571 · Technology Transfer Intl., Inc. · Feb 1991
AVI MODEL 600 SYRINGE PUMP, MODIFICATION
K904979 · 3M Avi, Inc. · Jan 1991
MODIFIED WALKMED 400
K905783 · Medfusion, Inc. · Jan 1991
MODEL 2001, MODIFICATION
K905029 · Medfusion, Inc. · Dec 1990
VERIFUSE AMBULATORY PUMP
K902891 · Block Medical, Inc. · Nov 1990
SYRINGE INFUSION PUMP
K903343 · Baxter Healthcare Corp · Nov 1990
K904403 · BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
Download PDF C.R. Bard, Inc.