Cleared Traditional

ABBOTT LIFECARE 4100 PCA INFUSER (K895710) - FDA 510(k) Clearance

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

K895710 · Abbott Laboratories · General Hospital
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Jul 1990
Decision
294d
Days
Class 2
Risk

K895710 is an FDA 510(k) clearance for the ABBOTT LIFECARE 4100 PCA INFUSER. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 16, 1990 after a review of 294 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 Abbott Laboratories devices

Submission Details

510(k) Number K895710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1989
Decision Date July 16, 1990
Days to Decision 294 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
165d slower than avg
Panel avg: 129d · This submission: 294d
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 235
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K895710.
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
BECTON DICKINSON 360 INFUSER (TM) SYSTEM
K902409 · Bd Becton Dickinson Vacutainer Systems Preanalytic · 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
TFV-2300 INFUSION PUMP
K890736 · Nihon Kohden America, Inc. · Jul 1990