Cleared Traditional

K905713 - BARD AMBULATORY PUMP TUBING SET

K905713 is the FDA 510(k) clearance for BARD AMBULATORY PUMP TUBING SET 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 206-day FDA review.

K905713 · C.R. Bard, Inc. · General Hospital
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Jul 1991
Decision
206d
Days
Class 2
Risk

K905713 is an FDA 510(k) clearance for the BARD AMBULATORY PUMP TUBING SET. 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 July 15, 1991 after a review of 206 days - an extended review cycle.

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 K905713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1990
Decision Date July 15, 1991
Days to Decision 206 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
77d slower than avg
Panel avg: 129d · This submission: 206d
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 K905713.
LIFECARE 4100 PCA INFUSER PLUS II
K912928 · Abbott Laboratories · Aug 1991
MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM
K911964 · Abbott Laboratories · Aug 1991
MODIFIED LIFECARE MODEL 175 INFUSER
K912092 · Abbott Laboratories · Aug 1991
EPIDURAL INDICATION FOR BAXTER INFUSORS ATTACHMENT
K905778 · Baxter Healthcare Corp · Jul 1991
BARD ALFENTANIL INFUSER
K904890 · C.R. Bard, Inc. · Jun 1991
FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM
K910934 · Baxter Healthcare Corp · Jun 1991