Cleared Traditional

K983838 - ABBOTT LIFECARE STANDARD TUBING INFUSIO...

K983838 is an FDA 510(k) clearance for ABBOTT LIFECARE STANDARD TUBING INFUSIO..., 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 30-day FDA review.

K983838 · Abbott Laboratories · General Hospital
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Nov 1998
Decision
30d
Days
Class 2
Risk

K983838 is an FDA 510(k) clearance for the ABBOTT LIFECARE STANDARD TUBING INFUSION 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 November 20, 1998 after a review of 30 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 - K983838

510(k) Number K983838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1998
Decision Date November 20, 1998
Days to Decision 30 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
99d faster than avg
Panel avg: 129d · This submission: 30d
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 K983838.
MEDEX 3000 SERIES SYRINGE INFUSION PUMP
K982640 · Medex, Inc. · Apr 1999
PERFUSOR COMPACT
K983005 · B.Braun Medical, Inc. · Feb 1999
ABBOTT PLUM A+ INFUSION PUMP
K982159 · Abbott Laboratories · Jan 1999
CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
K982838 · Sims Deltec, Inc. · Nov 1998
CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM
K982836 · Sims Deltec, Inc. · Nov 1998
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X
K981776 · Alexander Mfg. Co. · Aug 1998