Cleared Traditional

K844730 - BARD HARVARD MINI-INFUSER 400 MULTI DOS...

K844730 is the FDA 510(k) clearance for BARD HARVARD MINI-INFUSER 400 MULTI DOS... 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 55-day FDA review.

K844730 · C.R. Bard, Inc. · General Hospital
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Jan 1985
Decision
55d
Days
Class 2
Risk

K844730 is an FDA 510(k) clearance for the BARD HARVARD MINI-INFUSER 400 MULTI DOSE SYRINGE. 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 January 28, 1985 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K844730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1984
Decision Date January 28, 1985
Days to Decision 55 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
74d faster than avg
Panel avg: 129d · This submission: 55d
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 K844730.
HOME PRO VOLUMETRIC INFUSION PUMP
K841374 · American Edwards Laboratories · Feb 1985
STRATOFUSE SYRINGE PIGGYBACK PUMP
K844627 · Strato Medical Corp. · Jan 1985
360 INFUSER
K844719 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1985
ABBOTT LIFECARE 900 VOLUMETRIC PUMP
K844091 · Abbott Laboratories · Jan 1985
ABBOTT LIFECARE 500 INFUSER
K844768 · Abbott Laboratories · Jan 1985
MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A
K844792 · Pacesetter Systems · Jan 1985