Cleared Traditional

K880733 - BARD PCA II INFUSION PUMP

K880733 is the FDA 510(k) clearance for BARD PCA II INFUSION PUMP 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 117-day FDA review.

K880733 · C.R. Bard, Inc. · General Hospital
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Jun 1988
Decision
117d
Days
Class 2
Risk

K880733 is an FDA 510(k) clearance for the BARD PCA II INFUSION PUMP. 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 June 20, 1988 after a review of 117 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 K880733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1988
Decision Date June 20, 1988
Days to Decision 117 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
12d faster than avg
Panel avg: 129d · This submission: 117d
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 K880733.
UVP VOLUMED 2001
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BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI.
K882556 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1988
IVAC VOLUMETRIC PUMP - MODEL 590
K875332 · Y · May 1988
SIM MODULE
K874546 · Critikon Company, LLC · May 1988
CADD-TPA(TM) MODEL 5600 AMBULATORY INFUSION PUMP
K880204 · Pharmacia Deltec, Inc. · Apr 1988