Cleared Traditional

K831761 - SIMPLICITY PLUS

K831761 is an FDA 510(k) clearance for SIMPLICITY PLUS, 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 72-day FDA review.

K831761 · Critikon Company, LLC · General Hospital
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Aug 1983
Decision
72d
Days
Class 2
Risk

K831761 is an FDA 510(k) clearance for the SIMPLICITY PLUS. 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 12, 1983 after a review of 72 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 - K831761

510(k) Number K831761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1983
Decision Date August 12, 1983
Days to Decision 72 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
57d faster than avg
Panel avg: 129d · This submission: 72d
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 K831761.
LIFECARE MICRO PUMP
K832289 · Abbott Laboratories · Sep 1983
GRASEBY DYNAMICS MS302 SYRINGE DRIVER
K832410 · Intermedics, Inc. · Sep 1983
FLO-GARD 8500 MICROINFUSION PUMP
K832166 · Travenol Laboratories, S.A. · Aug 1983
INFUTROL 7000 INFUSION PUMP
K832008 · Valleylab, Inc. · Aug 1983
PROMINJET PUMP
K832120 · Abbott Laboratories · Aug 1983
ENTERNAL PUMP & ADMIN. SET 430
K831935 · Imed Corp. · Aug 1983