Cleared Traditional

K844768 - ABBOTT LIFECARE 500 INFUSER

K844768 is an FDA 510(k) clearance for ABBOTT LIFECARE 500 INFUSER, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K844768 · Abbott Laboratories · General Hospital
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Jan 1985
Decision
49d
Days
Class 2
Risk

K844768 is an FDA 510(k) clearance for the ABBOTT LIFECARE 500 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 January 25, 1985 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K844768

510(k) Number K844768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1984
Decision Date January 25, 1985
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.

FRN Device Classification - Class 2, Special Controls

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 459
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K844768.
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 900 VOLUMETRIC PUMP
K844091 · Abbott Laboratories · Jan 1985
MINIMED EXTERNAL INFUSION PUMP FOR DIABETICS 502A
K844792 · Pacesetter Systems · Jan 1985
MINIMED EXTERNAL INFUSION PUMP FOR DIAGETICS 504
K844851 · Pacesetter Systems · Jan 1985
I.V. PUMP ADMINISTRATION SET
K843949 · Travenol Laboratories, S.A. · Nov 1984