Cleared Traditional

BARD PCA II PUMP WITH PROGRAM CARTRIDGES (K921994) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K921994 · C.R. Bard, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 30
Devices cleared under the same product code (MEA) and FDA review panel - the closest regulatory comparables to K921994.
MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM)
K051253 · Baxter Healthcare Corp · Jul 2005
SYNDEO PCA SYRINGE PUMP, MODEL 2L3113
K031566 · Baxter Healthcare Corp · Aug 2003
ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384
K022203 · Abbott Laboratories · Aug 2002
INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K
K002739 · Baxter Healthcare Corp · Sep 2000
BARD PCA II PUMP WITH PROGRAM CARTRIDGES
K914502 · C.R. Bard, Inc. · Dec 1991