Cleared Traditional

ABBOTT LIFECARE 900 VOLUMETRIC PUMP (K844091) - FDA 510(k) Clearance

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

K844091 · Abbott Laboratories · General Hospital
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Jan 1985
Decision
95d
Days
Class 2
Risk

K844091 is an FDA 510(k) clearance for the ABBOTT LIFECARE 900 VOLUMETRIC PUMP. 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 January 25, 1985 after a review of 95 days - within the typical 510(k) review window.

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 K844091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1984
Decision Date January 25, 1985
Days to Decision 95 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
34d faster than avg
Panel avg: 129d · This submission: 95d
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 K844091.
PROMINJECT PROGRAMMABLE INFUSION PUMP
K850669 · Pharmacia, Inc. · Apr 1985
360 INFUSER
K844719 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1985
BARD HARVARD MINI-INFUSER 400 MULTI DOSE SYRINGE
K844730 · C.R. Bard, Inc. · Jan 1985
ABBOTT LIFECARE 500 INFUSER
K844768 · Abbott Laboratories · Jan 1985
I.V. PUMP ADMINISTRATION SET
K843949 · Travenol Laboratories, S.A. · Nov 1984
INTERMEDICS/GRASEBY DYNAMICS MS 36
K843331 · Intermedics, Inc. · Nov 1984