Cleared Traditional

DURAFUSE INFUSION PUMP (K920773) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K920773 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
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May 1992
Decision
78d
Days
Class 2
Risk

K920773 is an FDA 510(k) clearance for the DURAFUSE INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 8, 1992 after a review of 78 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K920773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1992
Decision Date May 08, 1992
Days to Decision 78 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 129d · This submission: 78d
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 231
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K920773.
BARD EPIDURAL PUMP
K925196 · C.R. Bard, Inc. · Jun 1993
LIFECARE 175 INFUSER -- MODIFICATION
K923829 · Abbott Laboratories · Apr 1993
PANCRETEC PROVIDER INFUSION PUMP -- MODIFICAITON
K923601 · Abbott Laboratories · Dec 1992
FLO-GARD 8000 HALF-SET
K915499 · Baxter Healthcare Corp · Mar 1992
PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF
K913931 · Abbott Laboratories · Mar 1992
FLO-GARD(R) 6201
K915522 · Baxter Healthcare Corp · Feb 1992