Cleared Traditional

K871807 - BARD MICROINFUSER I INSULIN INFUSION PUMP

K871807 is the FDA 510(k) clearance for BARD MICROINFUSER I INSULIN 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 222-day FDA review.

K871807 · C.R. Bard, Inc. · General Hospital
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Dec 1987
Decision
222d
Days
Class 2
Risk

K871807 is an FDA 510(k) clearance for the BARD MICROINFUSER I INSULIN INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on December 16, 1987 after a review of 222 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 K871807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1987
Decision Date December 16, 1987
Days to Decision 222 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
93d slower than avg
Panel avg: 129d · This submission: 222d
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 K871807.
IVAC MODEL 560+ SERIES VOLUMETRIC INFUSION PUMP
K873884 · Y · Jan 1988
BETATRON IV SYSTEM
K872774 · Cardiac Pacemakers, Inc. · Jan 1988
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
K873522 · C.R. Bard, Inc. · Dec 1987
IVAC(R) DUAL RATE SET - MODEL C50066
K873938 · Y · Dec 1987
CORMED III AMBULATORY INFUSION PUMP
K873847 · C.R. Bard, Inc. · Dec 1987
IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580+
K873776 · Y · Dec 1987