Cleared Traditional

K921994 - BARD PCA II PUMP WITH PROGRAM CARTRIDGES

K921994 is an FDA 510(k) clearance for BARD PCA II PUMP WITH PROGRAM CARTRIDGES, manufactured by C.R. Bard, Inc.. The device is a Class 2 General Hospital device with product code MEA cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K921994 · C.R. Bard, Inc. · General Hospital
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Aug 1992
Decision
97d
Days
Class 2
Risk

K921994 is an FDA 510(k) clearance for the BARD PCA II PUMP WITH PROGRAM CARTRIDGES. Classified as Pump, Infusion, Pca (product code MEA), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (North Reading, US). The FDA issued a Cleared decision on August 3, 1992 after a review of 97 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 - K921994

510(k) Number K921994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1992
Decision Date August 03, 1992
Days to Decision 97 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 129d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEA Device Classification - Class 2, Special Controls

Product Code MEA Pump, Infusion, Pca
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 - MEA Pump, Infusion, Pca

All 21
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K921994.
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CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300
K982839 · Sims Deltec, Inc. · Nov 1998
MODEL 6100 AMBULATORY INFUSION SYSTEM
K943310 · Pharmacia Deltec, Inc. · Feb 1995
IVAC PC ANIFUSER
K915063 · Y · Jun 1992
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K914502 · C.R. Bard, Inc. · Dec 1991
CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP
K911791 · Pharmacia Deltec, Inc. · Jun 1991