Cleared Traditional

K904403 - BARD AMBULATORY PCA DRUG DELIVERY SYSTEM

K904403 is the FDA 510(k) clearance for BARD AMBULATORY PCA DRUG DELIVERY SYSTEM by C.R. Bard, Inc.. It is a Class 2 General Hospital device (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.

View all C.R. Bard, Inc. devices

Submission Details

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.

Device Classification

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 433
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K904403.
LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH.
K910425 · Baxter Healthcare Corp · Apr 1991
MODIFIED VOLUMETRIC INFUSION PUMPS ATTACHMENTS
K910523 · Baxter Healthcare Corp · Mar 1991
STRATOFUSE PCA INFUSER
K905696 · Strato Medical Corp. · Mar 1991
SYRINGE INFUSION PUMP
K903343 · Baxter Healthcare Corp · Nov 1990
BARD MICROBORE ANTI-SIPHON NITRO SET
K900217 · C.R. Bard, Inc. · Oct 1990
IVAC(R) SYRINGE PUMP - MODEL 770
K901550 · Y · Oct 1990