Cleared Traditional

LIFECARE 175 INFUSER -- MODIFICATION (K923829) - FDA 510(k) Clearance

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

K923829 · Abbott Laboratories · General Hospital
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Apr 1993
Decision
259d
Days
Class 2
Risk

K923829 is an FDA 510(k) clearance for the LIFECARE 175 INFUSER -- MODIFICATION. 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 April 7, 1993 after a review of 259 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 K923829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1992
Decision Date April 07, 1993
Days to Decision 259 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 129d · This submission: 259d
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 K923829.
KVOI.V. FLUSH SYSTEM
K923224 · Baxter Healthcare Corp · Feb 1994
ABBOTT PLUM XL INFUSION PUMP
K931375 · Abbott Laboratories · Sep 1993
BARD EPIDURAL PUMP
K925196 · C.R. Bard, Inc. · Jun 1993
PANCRETEC PROVIDER INFUSION PUMP -- MODIFICAITON
K923601 · Abbott Laboratories · Dec 1992
DURAFUSE INFUSION PUMP
K920773 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1992
FLO-GARD 8000 HALF-SET
K915499 · Baxter Healthcare Corp · Mar 1992