Cleared Traditional

K883645 - LIFECARE MICRO PUMP

K883645 is an FDA 510(k) clearance for LIFECARE MICRO PUMP, 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 357-day FDA review.

K883645 · Abbott Laboratories · General Hospital
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Aug 1989
Decision
357d
Days
Class 2
Risk

K883645 is an FDA 510(k) clearance for the LIFECARE MICRO 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 August 17, 1989 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K883645

510(k) Number K883645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1988
Decision Date August 17, 1989
Days to Decision 357 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
228d slower than avg
Panel avg: 129d · This submission: 357d
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 K883645.
MODEL 280 INFUSION PUMP
K894360 · 3M Company · Oct 1989
MULTI-DRUG(TM) INFUSION SYSTEM
K892210 · I-Flow Corp. · Aug 1989
IVAC(R) SPACE.SAVER(TM) VOLUMETRIC PUMP MODEL 599
K894037 · Y · Aug 1989
IVSK09 CALIBRATION KIT AN ACCESSORY TO IV7000/7200
K890786 · Valleylab, Inc. · Jul 1989
60 MICROBORE EXTENSION SET W/ANTI-SIPHON VALVE
K892906 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1989
BASAL/BOLUS INFUSORS
K884505 · Baxter Healthcare Corp · Jul 1989