Cleared Traditional

K803078 - SIMPLICITY INFUSION PUMP MODEL 2100A

K803078 is an FDA 510(k) clearance for SIMPLICITY INFUSION PUMP MODEL 2100A, manufactured by Critikon Company, LLC. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K803078 · Critikon Company, LLC · General Hospital
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Jan 1981
Decision
54d
Days
Class 2
Risk

K803078 is an FDA 510(k) clearance for the SIMPLICITY INFUSION PUMP MODEL 2100A. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Critikon Company, LLC (Mchenry, US). The FDA issued a Cleared decision on January 28, 1981 after a review of 54 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 Critikon Company, LLC devices

FDA 510(k) Submission Details - K803078

510(k) Number K803078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1980
Decision Date January 28, 1981
Days to Decision 54 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
75d faster than avg
Panel avg: 129d · This submission: 54d
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 463
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K803078.
OPEN LOOP AMBULATORY INFUSION DEVICE
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MODEL 560 SERIES VOLUMETRIC INFUSION
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COMPUTER INTERFACE MODULE
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TRAVENOL INFUSION PUMP-2M8016
K802901 · Travenol Laboratories, S.A. · Dec 1980
TRAVENOL 24 HR. INFUSOR (ELASTOMERIC PP)
K802820 · Travenol Laboratories, S.A. · Dec 1980
CORDIS DOW INFUSION PUMP
K802301 · Cordis Corp. · Oct 1980