Cleared Traditional

K883796 - LIFECARE MICRO PUMP

K883796 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 174-day FDA review.

K883796 · Abbott Laboratories · General Hospital
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Feb 1989
Decision
174d
Days
Class 2
Risk

K883796 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 February 28, 1989 after a review of 174 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

FDA 510(k) Submission Details - K883796

510(k) Number K883796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1988
Decision Date February 28, 1989
Days to Decision 174 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
45d slower than avg
Panel avg: 129d · This submission: 174d
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 K883796.
RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP
K890282 · Abbott Laboratories · Apr 1989
CADD-PCA MODEL 5800 AMBULATORY INFUSION PUMP
K890062 · Pharmacia Deltec, Inc. · Mar 1989
MODIFIED MINIMED MDL404-SP/504-S DRUG INSULIN PUMP
K890457 · Medtronic Minimed · Mar 1989
MODIFIED IMED GEMINI PC-1 INFUSION PUMP
K883993 · Imed Corp. · Dec 1988
FLO-GARD VP
K884014 · Baxter Healthcare Corp · Dec 1988
BARD INFUSOR PUMP
K883577 · C.R. Bard, Inc. · Nov 1988