Cleared Traditional

BECTON DICKINSON PROGRAM 2 INFUSION PUMP (K900375) - FDA 510(k) Clearance

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

K900375 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
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Aug 1990
Decision
188d
Days
Class 2
Risk

K900375 is an FDA 510(k) clearance for the BECTON DICKINSON PROGRAM 2 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 August 2, 1990 after a review of 188 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K900375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1990
Decision Date August 02, 1990
Days to Decision 188 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
59d slower than avg
Panel avg: 129d · This submission: 188d
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 K900375.
AMBULATORY INFUSER AND ASSOC. FLOW CONTROLLING SET
K902432 · Abbott Laboratories · Sep 1990
LIFECARE MODEL 4 PUMP
K900467 · Abbott Laboratories · Aug 1990
LIFECARE(R) MODEL 3 PUMP
K900468 · Abbott Laboratories · Aug 1990
BECTON DICKINSON 360 INFUSER (TM) SYSTEM
K902409 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1990
ABBOTT LIFECARE 4100 PCA INFUSER
K895710 · Abbott Laboratories · Jul 1990
ABBOTT PATIENT CONTROLLED ANALGESIA (PCA) PUMP
K895709 · Abbott Laboratories · Jul 1990