Cleared Traditional

K801546 - THE SIMPLICITY PUMP #2100 INFUSION PUMP

K801546 is an FDA 510(k) clearance for THE SIMPLICITY PUMP #2100 INFUSION PUMP, 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 51-day FDA review.

K801546 · Critikon Company, LLC · General Hospital
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Aug 1980
Decision
51d
Days
Class 2
Risk

K801546 is an FDA 510(k) clearance for the THE SIMPLICITY PUMP #2100 INFUSION PUMP. 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 August 27, 1980 after a review of 51 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 - K801546

510(k) Number K801546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1980
Decision Date August 27, 1980
Days to Decision 51 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
78d faster than avg
Panel avg: 129d · This submission: 51d
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 K801546.
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
OPEN-LOOP INSULIN DELIVERY SYSTEM
K801704 · Delta Medical Industries · Aug 1980
KANGAROO ENTERAL FEEDING PUMP
K801725 · Chesebrough-Pond'S U.S.A. Co. · Aug 1980
ABBOTT/SHAW LIFE CARE PUMP MODEL 3
K801441 · Abbott Laboratories · Aug 1980