Cleared Traditional

K812035 - IMED ACCUSET CASSETTE

K812035 is the FDA 510(k) clearance for IMED ACCUSET CASSETTE by Imed Corp.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K812035 · Imed Corp. · General Hospital
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Jul 1981
Decision
8d
Days
Class 2
Risk

K812035 is an FDA 510(k) clearance for the IMED ACCUSET CASSETTE. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Imed Corp. (Walker, US). The FDA issued a Cleared decision on July 28, 1981 after a review of 8 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 Imed Corp. devices

Submission Details

510(k) Number K812035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1981
Decision Date July 28, 1981
Days to Decision 8 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 129d · This submission: 8d
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 306
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K812035.
3M INFUSION SYSTEM
K812442 · 3M Company · Sep 1981
TERUFUSION INFUSION PUMP MODEL STC-502
K812339 · Terumo Medical Corp. · Sep 1981
VOLUMETRIC INFUSION PUMP
K812021 · American Edwards Laboratories · Jul 1981
IVAC 700 SYRINGE INFUSION PUMP
K811884 · Y · Jul 1981
ENTRI ENTERAL FEEDING PUMP
K811739 · Biosearch Medical Products, Inc. · Jul 1981
OPEN LOOP AMBULATORY INFUSION DEVICE
K811774 · Cardiac Pacemakers, Inc. · Jul 1981