Cleared Traditional

BECTON DICKINSON 360 INFUSER (TM) SYSTEM (K902409) - FDA 510(k) Clearance

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

K902409 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
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Jul 1990
Decision
49d
Days
Class 2
Risk

K902409 is an FDA 510(k) clearance for the BECTON DICKINSON 360 INFUSER (TM) SYSTEM. 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 July 19, 1990 after a review of 49 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 K902409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1990
Decision Date July 19, 1990
Days to Decision 49 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
80d faster than avg
Panel avg: 129d · This submission: 49d
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 K902409.
LIFECARE MODEL 4 PUMP
K900467 · Abbott Laboratories · Aug 1990
LIFECARE(R) MODEL 3 PUMP
K900468 · Abbott Laboratories · Aug 1990
BECTON DICKINSON PROGRAM 2 INFUSION PUMP
K900375 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
ABBOTT LIFECARE 4100 PCA INFUSER
K895710 · Abbott Laboratories · Jul 1990
ABBOTT PATIENT CONTROLLED ANALGESIA (PCA) PUMP
K895709 · Abbott Laboratories · Jul 1990
RATE INFUSER PLUS
K900742 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1990