Cleared Traditional

K902613 - BARD PCA II PUMP WITH PROGRAM CARTRIDGES

K902613 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 FRN cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K902613 · C.R. Bard, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
310d
Days
Class 2
Risk

K902613 is an FDA 510(k) clearance for the BARD PCA II PUMP WITH PROGRAM CARTRIDGES. 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 April 19, 1991 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K902613

510(k) Number K902613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1990
Decision Date April 19, 1991
Days to Decision 310 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
181d slower than avg
Panel avg: 129d · This submission: 310d
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 581
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K902613.
ABBOTT LIFECARE 5000 PUMP MODIFIED
K910919 · Abbott Laboratories · May 1991
EPIDURAL INDICATION FOR BAXTER SYRINGE INFUS PUMP
K911289 · Baxter Healthcare Corp · May 1991
MENTOR(R) SUR-E-TROL(R)
K910637 · Mentor O & O, Inc. · May 1991
EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS
K910428 · Baxter Healthcare Corp · Apr 1991
LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH.
K910425 · Baxter Healthcare Corp · Apr 1991
MODIFIED VOLUMETRIC INFUSION PUMPS ATTACHMENTS
K910523 · Baxter Healthcare Corp · Mar 1991