Cleared Traditional

K904890 - BARD ALFENTANIL INFUSER

K904890 is the FDA 510(k) clearance for BARD ALFENTANIL INFUSER 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 237-day FDA review.

K904890 · C.R. Bard, Inc. · General Hospital
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Jun 1991
Decision
237d
Days
Class 2
Risk

K904890 is an FDA 510(k) clearance for the BARD ALFENTANIL INFUSER. 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 24, 1991 after a review of 237 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 K904890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1990
Decision Date June 24, 1991
Days to Decision 237 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
108d slower than avg
Panel avg: 129d · This submission: 237d
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 K904890.
MODIFIED LIFECARE MODEL 175 INFUSER
K912092 · Abbott Laboratories · Aug 1991
BARD AMBULATORY PUMP TUBING SET
K905713 · C.R. Bard, Inc. · Jul 1991
EPIDURAL INDICATION FOR BAXTER INFUSORS ATTACHMENT
K905778 · Baxter Healthcare Corp · Jul 1991
FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM
K910934 · Baxter Healthcare Corp · Jun 1991
MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED
K912458 · Medtronic Minimed · Jun 1991
RATEMINDER(TM) V INFUSION PUMP, MODIFICATION
K911769 · Critikon Company, LLC · Jun 1991